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)
120
Enrollment
1
Location
2
Arms
25.8
Actual Duration (Months)
4.6
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Walter Reed National Military Medical Center (WRNMMC)BethesdaMarylandUnited States20889

    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)

    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:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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
    STARTED6060
    COMPLETED6060
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitlePlain BupivacaineExparel Plus Plain BupivacaineTotal
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 colporrhaphyTotal of all reporting groups
    Overall Participants6060120
    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
    TitleChange 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
    DescriptionPatients 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 FrameSubjects will be asked to provide numerical values on postoperative day 1.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [score on a scale]
    2
    0
    2. Primary Outcome
    TitleChange 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
    DescriptionPatients 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 FrameSubjects will be asked to provide numerical values on postoperative day 2.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [score on a scale]
    3
    2
    3. Primary Outcome
    TitleChange 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
    DescriptionPatients 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 FrameSubjects will be asked to provide numerical values on postoperative day 3.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [score on a scale]
    3
    2
    4. Secondary Outcome
    TitleAmount Ibuprofen Pain Medication Required During the Postoperative Period at Home
    DescriptionCalculate 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 FrameCalculated 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 TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [milligrams]
    3600
    2400
    5. Secondary Outcome
    TitleAmount Acetaminophen Pain Medication Required During the Postoperative Period at Home
    DescriptionCalculate 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 FrameCalculated 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 TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [milligrams]
    4000
    3250
    6. Secondary Outcome
    TitleAmount Opioid Pain Medication Required During the Postoperative Period (Through Day 3)
    DescriptionCalculate 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 FrameCalculated 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 TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [morphine milligram equivalents]
    45.0
    57.1
    7. Secondary Outcome
    TitlePercentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
    DescriptionInvestigators will record in patients passed active voiding trail prior to discharge home.
    Time FramePostoperative active voiding trial on postoperative day 1.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Number [percentage passed]
    82
    72
    8. Secondary Outcome
    TitleRate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
    DescriptionInvestigators will record in patients have had a bowel movement within the first three days postoperatively.
    Time FramePostoperatively up to day 3

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Number [percentage of patients]
    71.6
    73.3
    9. Secondary Outcome
    TitleImpact 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
    DescriptionInvestigators 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 FrameSubjects will be asked to provide numerical value on postoperative day 3.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [score on a scale]
    3.5
    3
    10. Secondary Outcome
    TitleImpact 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
    DescriptionInvestigators 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 FrameSubjects will be asked to provide numerical value on postoperative day 3.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [score on a scale]
    0.500
    1
    11. Secondary Outcome
    TitleImpact 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
    DescriptionInvestigators 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 FrameSubjects will be asked to provide numerical value on postoperative day 3.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [score on a scale]
    1
    1
    12. Secondary Outcome
    TitleImpact 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
    DescriptionInvestigators 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 FrameSubjects will be asked to provide numerical value on postoperative day 3.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 Participants6060
    Median (Inter-Quartile Range) [score on a scale]
    0
    1

    Adverse Events

    Time Frameentirety of the study (AUG2018-AUG2020); patients were followed out to 6 weeks postoperatively
    Adverse Event Reporting Description
    Arm/Group TitlePlain BupivacaineExparel Plus Plain Bupivacaine
    Arm/Group Description20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy10 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 BupivacaineExparel Plus Plain Bupivacaine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/60 (0%) 0/60 (0%)
    Serious Adverse Events
    Plain BupivacaineExparel Plus Plain Bupivacaine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/60 (0%) 0/60 (0%)
    Other (Not Including Serious) Adverse Events
    Plain BupivacaineExparel Plus Plain Bupivacaine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total3/60 (5%) 4/60 (6.7%)
    Musculoskeletal and connective tissue disorders
    Postoperative sensory numbness/tingling in the lower extremities3/60 (5%) 34/60 (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.

    Results Point of Contact

    Name/TitleKatherine L Dengler, MD
    OrganizationWalter Reed National Military Medical Center
    Phone301-400-2468
    Emailkatherine.l.dengler.mil@mail.mil
    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