Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

• Sponsor: Lauren Giugale, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03040011
• Collaborator: Magee-Womens Research Institute (Other)
• Enrollment: 79
• Location: 1
• Arms: 3
• Actual Duration (Months): 26.1
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total of 75 women will be performed.

The study population will be adult women (>18 years of age) with uterovaginal or vaginal vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which includes an apical support procedure. Participants will be enrolled prior to surgery. The procedure will involved four injection sites: the bilateral levator ani muscles via a transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random assignment will occur to one of three study arms: combined arm (20 milliliters bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20 milliliters saline divided between the 4 injection sites).

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse; Surgery; Postoperative Pain	Drug: Dexamethasone; Drug: Bupivacaine; Procedure: Bilateral Pudendal Nerve Block; Procedure: Bilateral Levator Ani Muscle Injection; Drug: Saline	Phase 1/Phase 2

Detailed Description

The primary purpose of this three arm, randomized clinical trial is to test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal native tissue apical reconstructive surgery.

Hypothesis: concurrent bilateral transobturator levator ani muscle injections and transvaginal pudendal nerve blocks with bupivacaine and dexamethasone performed prior to vaginal apical support procedures will result in improved pain scores at 24 hours postoperatively.

Participants will be randomized to three arms: bupivacaine/dexamethasone group, bupivacaine group, and placebo group. Block randomization will occur and will be stratified by surgery type to ensure that similar numbers of each procedure are randomized to each study arm.

All 3 groups will receive pudendal nerve blocks and transobturator levator ani muscle injections as outlined in detail below (with either bupivacaine/dexamethasone, bupivacaine alone or saline depending on randomization). The interventions will be performed after the participant is positioned in lithotomy position and after sterile preparation of the vagina and perineum per standard protocol. These injections will be performed at the start of the procedure prior to any vaginal repair and be administered by either the attending surgeon or the urogynecology fellow. After the interventions below, the vaginal reconstructive procedures will be performed as usual by the attending surgeon and surgical team. There are both fellows and residents who participate in these vaginal reconstructive surgeries, however for study purposes, resident physicians will not be permitted to administer either the pudendal nerve block or the transobturator injections. There are four attending surgeons and four fellow physicians who will be administering the injections. While all surgeons are familiar with the anatomy and have performed these procedures, each physician will be instructed on the intended procedures and additionally will be directly observed in the operating room for at least one procedure to ensure consistency in technique. All participants will undergo a standardized general anesthesia regimen.

After the study intervention, all participants will then undergo the scheduled vaginal reconstructive procedure as standard. Infiltration of the vaginal epithelium with lidocaine is common in vaginal repairs. The maximum doses of lidocaine and bupivacaine are additive. The amount of local infiltration to 50 milliliters of 0.5% lidocaine with epinephrine. This dose is equal to 250mg of lidocaine which, when also taking into account the 50mg of bupivacaine, is within a safe dosing range for a participant weighing 50kg.

Administration of all four injections involved in the study protocol and described above take approximately 5 additional minutes in total at the start of the case. After the injections are performed, there will be no further interventions.

Other assessments that will be performed as part of the study protocol are outlined below:

Baseline assessments: Pain assessment, assessment of presence of any baseline nausea or vomiting, baseline activities assessment will all be performed in preoperative area on the day of surgery prior to randomization.

Postoperative pain score assessment: 3 hours, 24 hours, 48 hours, 72 hours, and 1 week postoperatively. Postoperative pain measured by the numerical rating scale (NRS). The NRS is a publicly available pain assessment tool that consists of an eleven point scale ranging from 0 to 10 (0 = no pain and 10 = worst possible pain) presented visually on a horizontal line. Participants are asked to report a number or mark on the scale. Previous studies have demonstrated its reliability, validity and ease of administration. The NRS was chosen because a systematic review article demonstrated higher compliance rates, better responsiveness and ease of use relative to visual analog scales. Additionally, the NRS has been shown to have strong validity and low error rates when used in an elderly (>60 years) postoperative patient population.

Postoperative nausea and vomiting assessment: 3 hours postoperatively The intensity of postoperative nausea and vomiting (PONV) using the PONV Intensity scale. The PONV scale is a four question assessment designed to measure clinically significant nausea and vomiting. It was initially validated in a general surgery population and has been validated in early postoperative gynecology patients. Clinically important nausea and vomiting is defined as a score greater than or equal to 50. This scale takes approximately 1 minute to complete and is publicly available. The amount of inpatient anti-emetic consumption will also be assessed. Any anti-emetic administered from surgery end time will be recorded as well as the dosage. Anti-emetic type and dosage will be recorded until the time of discharge.

Voiding status at time of foley catheter removal. All patients routinely have some assessment of voiding function prior to discharge. Whether each participant passed or failed a voiding trial after surgery will be recorded in the database. If a participant fails, the standard of care is do be discharged to home after learning self-catheterization or with a foley catheter. In the event that a participant fails a postoperative voiding trial, whether participants receive a foley catheter or were performing self-catheterization will be recorded. As this is a routine part of postoperative care, the research protocol will not interfere with the performance or outcomes of a voiding trial. Results will be documented, however no specific assessment tool will be used.

Time to resume normal activities measured by the activities assessment scale (AAS): 1 week, 2 weeks, 6 weeks and 12 weeks postoperatively The AAS was initially designed to assess functional activity in the perioperative period in the general surgery population. It has since been deemed a valid and reliable measure to assess postoperative activity level in a Female Pelvic Medicine and Reconstructive Surgery patient population. It has the ability to measure perioperative function and takes approximately 3-5 minutes to complete. It consists of a 13 item questionnaire assessing various types of physical activity and the degree of difficulty associated with each activity. The types of activities assessed fall into three subscales: sedentary activities (questions 1-4), ambulatory activities (questions 6-8), and work or exercise activities (questions 11-13). Respondents also have the option to indicate that these activities were not performed for another indication (this item is not scored). The time frame for all questions is the previous 24 hours. Given that many patients are instructed to avoid strenuous work or exercise activity in the postoperative period, the subscales of sedentary activities and ambulatory activities, which patients are encouraged to perform as tolerated in the postoperative period, will be of most interest.

Consumption of analgesic medications: during inpatient hospital stay and for first 72 hours postoperatively Narcotic consumption will be measured in morphine equivalents. The amount of narcotics will be obtained from the inpatient hospital record. All narcotics received from the surgery end time to the time of discharge will be included. Morphine equivalents will be calculated with online calculator available at http://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm. Similarly, the amount of NSAIDs will be obtained from the inpatient hospital record. All NSAIDs received from the surgery end time to the time of discharge will be included. To assess both the amount of narcotic and NSAID consumption after discharge, the participant will be provided with a diary form to record how many daily tablets of narcotic and NSAIDs are taken. This form will be completed from postoperative days 1-3.

For all forms, the participants will be instructed to mail the forms back to the office once completed (in a pre-address envelope provided as part of the study). Participants will also have the option of brining the forms in to the office at the time of a participant's postoperative visit.

Participants, physicians and any nursing personnel involved in patient care will remain masked until 12 weeks postoperatively.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Three-arm, double-blinded, placebo-controlled, randomized controlled trialThree-arm, double-blinded, placebo-controlled, randomized controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blinded
• Primary Purpose: Treatment
• Official Title: Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block With Bupivacaine and Dexamethasone for Improved Pain Control After Vaginal Reconstructive Surgery: A Three-Arm Randomized Controlled Trial
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Apr 11, 2019
• Actual Study Completion Date: Aug 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine/Dexamethasone Arm After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.	Drug: Dexamethasone; Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.; Other Names: Decadron ; Drug: Bupivacaine; Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.; Other Names: Marcaine ; Procedure: Bilateral Pudendal Nerve Block; Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.; Procedure: Bilateral Levator Ani Muscle Injection; Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.
Active Comparator: Bupivacaine Arm After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.	Drug: Bupivacaine; Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.; Other Names: Marcaine ; Procedure: Bilateral Pudendal Nerve Block; Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.; Procedure: Bilateral Levator Ani Muscle Injection; Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.
Placebo Comparator: Placebo Arm After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.	Procedure: Bilateral Pudendal Nerve Block; Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.; Procedure: Bilateral Levator Ani Muscle Injection; Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.; Drug: Saline; Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.; Other Names: Normal Saline

Outcome Measures

Primary Outcome Measures

1. Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS) [24 hours postoperatively]

   Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

Secondary Outcome Measures

1. 6 Hour Postoperative Pain Measured by the NRS [6 hours postoperatively]

   Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.

2. POD 2 Postoperative Pain Measured by the NRS [2 days after surgery]

   Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

3. POD 3 Postoperative Pain Measured by the NRS [3 days after surgery]

   Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

4. 1 Week Postoperative Pain Measured by the NRS [1 week after surgery]

   Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

5. Proportion of Patients With Same Day Discharge [Day of surgery]

   Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.

6. Postoperative Urinary Retention [0-24 hours postoperatively]

   Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.

7. Adverse Events [0-12 weeks postoperatively]

   The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.

8. Nausea and Vomiting Measured by the PONV Scale [6 hours postoperatively]

   Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.

9. Anti-emetic Consumption [3 hours postoperatively]

   The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication

10. Return to Baseline Activities Using the Activities Assessment Scale [1 week postoperative]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

11. Return to Baseline Activities Using the Activities Assessment Scale [2 week postoperative]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

12. Return to Baseline Activities Using the Activities Assessment Scale [6 weeks postoperative]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

13. Return to Baseline Activities Using the Activities Assessment Scale [12 weeks postoperative]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

14. POD 1 Narcotic Consumption [Postoperative day 1]

    The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.

15. POD 2 Narcotic Consumption [Postoperative day 2]

    The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.

16. POD 3 Narcotic Consumption [Postoperative day 3]

    The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.

17. POD 1 Ibuprofen Consumption [Postoperative day 1]

    The total amount of ibuprofen medication used on postoperative day 1.

18. POD 2 Ibuprofen Consumption [Postoperative day 2]

    The total amount of ibuprofen medication used on postoperative day 2.

19. POD 3 Ibuprofen Consumption [Postoperative day 3]

    The total amount of ibuprofen medication used on postoperative day 3.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Women ages 18 or older who are scheduled for a vaginal native tissue repair with apical support procedure including uterosacral ligament suspension, sacrospinous ligament fixation, or colpectomy and colpocleisis with or without levator myorrhaphy

2. Concomitant procedures including hysterectomy, anterior and posterior colporrhaphies , perineorrhaphies and midurethral sling placements are acceptable and do not result in exclusion

3. Available for at least 12 weeks of follow-up

4. Able to undergoing general anesthesia

Exclusion Criteria:

1. Planned mesh-augmented apical support procedure (placement of synthetic midurethral sling is acceptable and not considered an exclusion criteria)

2. Planned mesh excision

3. Laparoscopic, robotic or abdominal surgery

4. Known adverse reaction or allergy to intervention medication

5. Evidence of fistula or known infection (vulvovaginal cellulitis, abscess, abdominopelvic infection, or systemic fungal infection)

6. Chronic pelvic pain as an active issue

7. Daily opiate consumption for any indication

8. History of pelvic radiation

9. Chronic steroid use

10. Diabetes mellitus

11. Known HIV/AIDS or immunosuppression secondary to transplant related medications

12. Planned surgery under regional anesthesia

13. Non-English speaking or inability to complete questionnaires

14. Bleeding disorders that would impair a patient's clotting ability

15. Weight less than 50kg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Lauren Giugale, MD
• Magee-Womens Research Institute

Investigators

• Principal Investigator: Lauren Giugale, MD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 24, 2019
• Informed Consent Form - Nov 6, 2018

More Information

Publications

• Bupivacaine: Drug Information. UpToDate; 2016.
• Dexamethasone (systemic): Drug information. UpToDate; 2016. Accessed November 9, 2016.
• Hsu D. Infiltration of local anesthetics. UpToDate. 2016. Accessed November 30, 2016.

• Responsible Party: Lauren Giugale, MD, MD, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03040011
• Other Study ID Numbers: PRO16110378
• First Posted: Feb 1, 2017
• Last Update Posted: Mar 9, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Lauren Giugale, MD, MD, University of Pittsburgh: Vaginal Surgery; Pelvic Organ Prolapse; Postoperative Pain
• Additional relevant MeSH terms: Pain, Postoperative; Prolapse; Pelvic Organ Prolapse; Dexamethasone; Bupivacaine

Study Results

Participant Flow

Pre-assignment Detail	After enrollment but before randomization, 4 patients withdrew from the study: surgical location changed (n=1), declined to participate (n=1), unsafe for general anesthesia (n=1), reported lidocaine allergy (n=1). Because they withdrew prior to randomization, we received permission to enroll an additional 4 patients to meet goal sample size of 75.

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Period Title: Received Randomized Study Intervention
STARTED	25	25	25
COMPLETED	25	25	25
NOT COMPLETED	0	0	0
Period Title: Received Randomized Study Intervention
STARTED	25	25	25
COMPLETED	21	24	24
NOT COMPLETED	4	1	1

Baseline Characteristics

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm	Total
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx	Total of all reporting groups
Overall Participants	25	25	25	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.8 (13.6)	68.0 (10.1)	70.2 (9.2)	69.0 (11.0)
Sex: Female, Male (Count of Participants)
Female	25 100%	25 100%	25 100%	75 100%
Male	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 8%	4 16%	0 0%	6 8%
White	22 88%	21 84%	24 96%	67 89.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 4%	0 0%	1 4%	2 2.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	25 100%	75 100%
Baseline NRS Pain Score (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	0	0	0	0
Baseline NV Score (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	0	0	0	0
Baseline AAS Score (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	94.6	92.3	95.5	94.2
Prolapse Procedure (Count of Participants)
Uterosacral Ligament Suspension	4 16%	8 32%	11 44%	23 30.7%
Sacrospinous Ligament Fixation	2 8%	3 12%	3 12%	8 10.7%
Colpocleisis	14 56%	9 36%	7 28%	30 40%
Levator Myorrhaphy	5 20%	5 20%	4 16%	14 18.7%

Outcome Measures

1. Primary Outcome

Title	Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)
Description	Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame	24 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	21	24	24
Median (Inter-Quartile Range) [score on a scale]	3.0	4.0	3.75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.39
	Comments
	Method	Kruskal-Wallis
	Comments

2. Secondary Outcome

Title	6 Hour Postoperative Pain Measured by the NRS
Description	Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.
Time Frame	6 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [score on a scale]	1.0	3.0	1.75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Kruskal-Wallis
	Comments

3. Secondary Outcome

Title	POD 2 Postoperative Pain Measured by the NRS
Description	Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame	2 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [score on a scale]	3.0	3.0	4.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Kruskal-Wallis
	Comments

4. Secondary Outcome

Title	POD 3 Postoperative Pain Measured by the NRS
Description	Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame	3 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [score on a scale]	3.0	2.5	3.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Kruskal-Wallis
	Comments

5. Secondary Outcome

Title	1 Week Postoperative Pain Measured by the NRS
Description	Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame	1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [score on a scale]	1.75	2.0	1.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Kruskal-Wallis
	Comments

6. Secondary Outcome

Title	Proportion of Patients With Same Day Discharge
Description	Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Count of Participants [Participants]	20 80%	22 88%	20 80%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Postoperative Urinary Retention
Description	Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.
Time Frame	0-24 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Count of Participants [Participants]	13 52%	11 44%	14 56%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Adverse Events
Description	The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.
Time Frame	0-12 weeks postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Number [number of adverse events]	7	6	9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	Nausea and Vomiting Measured by the PONV Scale
Description	Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.
Time Frame	6 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [score on a scale]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	Kruskal-Wallis
	Comments

10. Secondary Outcome

Title	Anti-emetic Consumption
Description	The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication
Time Frame	3 hours postoperatively

Outcome Measure Data

Analysis Population Description

This data was not collected. Rather, we assessed the PONV score which is described in outcome number 9.

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	0	0	0

11. Secondary Outcome

Title	Return to Baseline Activities Using the Activities Assessment Scale
Description	Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
Time Frame	1 week postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Count of Participants [Participants]	11 44%	11 44%	12 48%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	Chi-squared
	Comments

12. Secondary Outcome

Title	Return to Baseline Activities Using the Activities Assessment Scale
Description	Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
Time Frame	2 week postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Count of Participants [Participants]	15 60%	16 64%	14 56%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.90
	Comments
	Method	Chi-squared
	Comments

13. Secondary Outcome

Title	Return to Baseline Activities Using the Activities Assessment Scale
Description	Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
Time Frame	6 weeks postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Count of Participants [Participants]	19 76%	17 68%	17 68%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments
	Method	Chi-squared
	Comments

14. Secondary Outcome

Title	Return to Baseline Activities Using the Activities Assessment Scale
Description	Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.
Time Frame	12 weeks postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Count of Participants [Participants]	21 84%	19 76%	18 72%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Chi-squared
	Comments

15. Secondary Outcome

Title	POD 1 Narcotic Consumption
Description	The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.
Time Frame	Postoperative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [oral morphine equivalents]	7.5	4.4	7.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Kruskal-Wallis
	Comments

16. Secondary Outcome

Title	POD 2 Narcotic Consumption
Description	The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.
Time Frame	Postoperative day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [oral morphine equivalents]	7.5	0.0	7.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	Kruskal-Wallis
	Comments

17. Secondary Outcome

Title	POD 3 Narcotic Consumption
Description	The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.
Time Frame	Postoperative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [oral morphine equivalents]	7.5	0.0	0.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	Kruskal-Wallis
	Comments

18. Secondary Outcome

Title	POD 1 Ibuprofen Consumption
Description	The total amount of ibuprofen medication used on postoperative day 1.
Time Frame	Postoperative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [milligrams]	1200	1200	1200

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments
	Method	Kruskal-Wallis
	Comments

19. Secondary Outcome

Title	POD 2 Ibuprofen Consumption
Description	The total amount of ibuprofen medication used on postoperative day 2.
Time Frame	Postoperative day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [milligrams]	1200	1200	1800

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	Method	Kruskal-Wallis
	Comments

20. Secondary Outcome

Title	POD 3 Ibuprofen Consumption
Description	The total amount of ibuprofen medication used on postoperative day 3.
Time Frame	Postoperative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine/Dexamethasone Arm	Bupivacaine Arm	Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
Measure Participants	25	25	25
Median (Inter-Quartile Range) [milligrams]	1200	1200	1800

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Time Frame	12 weeks from the date of surgery
Adverse Event Reporting Description	Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
Arm/Group Title	Bupivacaine/Dexamethasone Arm		Bupivacaine Arm		Placebo Arm
Arm/Group Description	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam		After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m		After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
All Cause Mortality
	Bupivacaine/Dexamethasone Arm		Bupivacaine Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Bupivacaine/Dexamethasone Arm		Bupivacaine Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/25 (0%)		2/25 (8%)
Injury, poisoning and procedural complications
Surgical complications	1/25 (4%)	1	0/25 (0%)	0	1/25 (4%)	1
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation	0/25 (0%)	0	0/25 (0%)	0	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Bupivacaine/Dexamethasone Arm		Bupivacaine Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/25 (24%)		6/25 (24%)		7/25 (28%)
Cardiac disorders
Intraoperative bradycardia	0/25 (0%)	0	0/25 (0%)	0	1/25 (4%)	1
Gastrointestinal disorders
Nausea and vomiting, diarrhea	0/25 (0%)	0	2/25 (8%)	2	0/25 (0%)	0
Infections and infestations
Fever	1/25 (4%)	1	0/25 (0%)	0	0/25 (0%)	0
Yeast Infection	0/25 (0%)	0	0/25 (0%)	0	1/25 (4%)	1
Wound infection	0/25 (0%)	0	1/25 (4%)	1	0/25 (0%)	0
Musculoskeletal and connective tissue disorders
Fall	0/25 (0%)	0	0/25 (0%)	0	1/25 (4%)	1
Nervous system disorders
Excess postoperative surgical pain	1/25 (4%)	1	1/25 (4%)	1	2/25 (8%)	2
Leg numbness	2/25 (8%)	2	1/25 (4%)	1	0/25 (0%)	0
Renal and urinary disorders
Urinary tract infection	2/25 (8%)	2	1/25 (4%)	1	2/25 (8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.