Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

• Sponsor: Walter Reed National Military Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT04032327
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited.

The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.

The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups.

Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Exparel plus plain bupivacaine; Drug: Bupivacaine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Injectable Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy: A Prospective, Randomized, Double-Blinded Trial
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Aug 25, 2020
• Actual Study Completion Date: Aug 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Plain Bupivacaine 20 mL of 0.25% plain bupivacaine	Drug: Bupivacaine; 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy; Other Names: marcaine
Active Comparator: Exparel plus plain bupivacaine 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed	Drug: Exparel plus plain bupivacaine; 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy; Other Names: extended release liposomal bupivacaine plus marcaine

Outcome Measures

Primary Outcome Measures

1. Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively [Subjects will be asked to provide numerical values on postoperative day 1.]

   Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

2. Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively [Subjects will be asked to provide numerical values on postoperative day 2.]

   Patients will be asked on postoperative day (POD) 2 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

3. Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively [Subjects will be asked to provide numerical values on postoperative day 3.]

   Patients will be asked on postoperative day (POD) 3 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

Secondary Outcome Measures

1. Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home [Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)]

   Calculate total postoperative ibuprofen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of ibuprofen utilized at home through postoperative day #3

2. Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home [Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)]

   Calculate total postoperative acetaminophen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of acetaminophen utilized at home through postoperative day #3

3. Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3) [Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized)]

   Calculate total postoperative opioid medications used while inpatient and perform pill counts on postoperative days 1, 2, 3 (done via a phone call or inpatient). This will allow calculation of total amount of opioid pain medications utilized through postoperative day #3

4. Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. [Postoperative active voiding trial on postoperative day 1.]

   Investigators will record in patients passed active voiding trail prior to discharge home.

5. Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. [Postoperatively up to day 3]

   Investigators will record in patients have had a bowel movement within the first three days postoperatively.

6. Impact of Vaginal Pain Scores on Quality of Life Measures (ACTIVITY) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group [Subjects will be asked to provide numerical value on postoperative day 3.]

   Investigators will ask patients "how is your vaginal pain impacting your ACTIVITY (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

7. Impact of Vaginal Pain Scores on Quality of Life Measure (SLEEP) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group [Subjects will be asked to provide numerical value on postoperative day 3.]

   Investigators will ask patients "how is your vaginal pain impacting your SLEEP (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

8. Impact of Vaginal Pain Scores on Quality of Life Measure (MOOD) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group [Subjects will be asked to provide numerical value on postoperative day 3.]

   Investigators will ask patients "how is your vaginal pain impacting your MOOD (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

9. Impact of Vaginal Pain Scores on Quality of Life Measure (STRESS) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group [Subjects will be asked to provide numerical value on postoperative day 3.]

   Investigators will ask patients "how is your vaginal pain impacting your STRESS (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Females >18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis including posterior colporrhaphy at Walter Reed National Military Medical Center.

• Patients must be able to read and understand written English or have an appropriate certified medical translator available.

Exclusion Criteria:

• Known allergy to amide local anesthetics.

• Unstable cardiac arrhythmia.

• Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer).

• Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable).

• Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery.

• Significant history of opioid or alcohol abuse or addiction (requiring treatment).

• Concurrent pain management requiring the use of epidural anesthesia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed National Military Medical Center (WRNMMC)	Bethesda	Maryland	United States	20889

Sponsors and Collaborators

• Walter Reed National Military Medical Center

Investigators

• Study Chair: Daniel Gruber, MD, Walter Reed National Military Medical Center (WRNMMC)

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 10, 2020

More Information

Publications

None provided.

• Responsible Party: Katherine Dengler, MD, FPMRS Fellow, Walter Reed National Military Medical Center
• ClinicalTrials.gov Identifier: NCT04032327
• Other Study ID Numbers: 11111
• First Posted: Jul 25, 2019
• Last Update Posted: Nov 18, 2021
• Last Verified: Nov 1, 2021

• 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.: Yes
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Period Title: Overall Study
STARTED	60	60
COMPLETED	60	60
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine	Total
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy	Total of all reporting groups
Overall Participants	60	60	120
Age (years) [Median (Inter-Quartile Range) ]
Plain Bupivacaine	49.5	49.5
Exparel Plus Plain Bupivacaine	51.0	51.0
Sex: Female, Male (Count of Participants)
Female	60 100%	60 100%	120 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.7%	1 1.7%	2 1.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 11.7%	9 15%	16 13.3%
White	46 76.7%	48 80%	94 78.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	6 10%	2 3.3%	8 6.7%
Body Mass Index (kg/m^2) [Median (Inter-Quartile Range) ]
Plain Bupivacaine	26.1	26.1
Exparel plus plain bupivacaine	25.9	25.9
Gravidity (pregnancies) [Median (Inter-Quartile Range) ]
Plain Bupivacaine	3	3
Exparel plus plain bupivacaine	3	3
Parity (births) [Median (Inter-Quartile Range) ]
Plain Bupivacaine	2	2
Exparel plus plain bupivacaine	3	3
colpopexy (Count of Participants)
none	12 20%	9 15%	21 17.5%
laparoscopic	32 53.3%	31 51.7%	63 52.5%
vaginal	16 26.7%	20 33.3%	36 30%
hysterectomy (Count of Participants)
none	21 35%	25 41.7%	46 38.3%
laparoscopic	30 50%	22 36.7%	52 43.3%
vaginal	9 15%	13 21.7%	22 18.3%

Outcome Measures

1. Primary Outcome

Title	Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively
Description	Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Time Frame	Subjects will be asked to provide numerical values on postoperative day 1.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [score on a scale]	2	0

2. Primary Outcome

Title	Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively
Description	Patients will be asked on postoperative day (POD) 2 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Time Frame	Subjects will be asked to provide numerical values on postoperative day 2.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [score on a scale]	3	2

3. Primary Outcome

Title	Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively
Description	Patients will be asked on postoperative day (POD) 3 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Time Frame	Subjects will be asked to provide numerical values on postoperative day 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [score on a scale]	3	2

4. Secondary Outcome

Title	Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home
Description	Calculate total postoperative ibuprofen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of ibuprofen utilized at home through postoperative day #3
Time Frame	Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [milligrams]	3600	2400

5. Secondary Outcome

Title	Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home
Description	Calculate total postoperative acetaminophen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of acetaminophen utilized at home through postoperative day #3
Time Frame	Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [milligrams]	4000	3250

6. Secondary Outcome

Title	Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3)
Description	Calculate total postoperative opioid medications used while inpatient and perform pill counts on postoperative days 1, 2, 3 (done via a phone call or inpatient). This will allow calculation of total amount of opioid pain medications utilized through postoperative day #3
Time Frame	Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [morphine milligram equivalents]	45.0	57.1

7. Secondary Outcome

Title	Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
Description	Investigators will record in patients passed active voiding trail prior to discharge home.
Time Frame	Postoperative active voiding trial on postoperative day 1.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Number [percentage passed]	82	72

8. Secondary Outcome

Title	Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
Description	Investigators will record in patients have had a bowel movement within the first three days postoperatively.
Time Frame	Postoperatively up to day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Number [percentage of patients]	71.6	73.3

9. Secondary Outcome

Title	Impact of Vaginal Pain Scores on Quality of Life Measures (ACTIVITY) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
Description	Investigators will ask patients "how is your vaginal pain impacting your ACTIVITY (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Time Frame	Subjects will be asked to provide numerical value on postoperative day 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [score on a scale]	3.5	3

10. Secondary Outcome

Title	Impact of Vaginal Pain Scores on Quality of Life Measure (SLEEP) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
Description	Investigators will ask patients "how is your vaginal pain impacting your SLEEP (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Time Frame	Subjects will be asked to provide numerical value on postoperative day 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [score on a scale]	0.500	1

11. Secondary Outcome

Title	Impact of Vaginal Pain Scores on Quality of Life Measure (MOOD) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
Description	Investigators will ask patients "how is your vaginal pain impacting your MOOD (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Time Frame	Subjects will be asked to provide numerical value on postoperative day 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [score on a scale]	1	1

12. Secondary Outcome

Title	Impact of Vaginal Pain Scores on Quality of Life Measure (STRESS) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group
Description	Investigators will ask patients "how is your vaginal pain impacting your STRESS (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3
Time Frame	Subjects will be asked to provide numerical value on postoperative day 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Bupivacaine	Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy	10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Measure Participants	60	60
Median (Inter-Quartile Range) [score on a scale]	0	1

Adverse Events

Time Frame	entirety of the study (AUG2018-AUG2020); patients were followed out to 6 weeks postoperatively
Arm/Group Title	Plain Bupivacaine		Exparel Plus Plain Bupivacaine
Arm/Group Description	20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy		10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
All Cause Mortality
	Plain Bupivacaine		Exparel Plus Plain Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Serious Adverse Events
	Plain Bupivacaine		Exparel Plus Plain Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Plain Bupivacaine		Exparel Plus Plain Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/60 (5%)		4/60 (6.7%)
Musculoskeletal and connective tissue disorders
Postoperative sensory numbness/tingling in the lower extremities	3/60 (5%)	3	4/60 (6.7%)	4

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.