Clinical trial NCT04032327: Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy
Official title: Efficacy of Injectable Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy: A Prospective, Randomized, Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2019-07-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Subjects will be asked to provide numerical values on postoperative day 1.
measure: 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
timeFrame: Subjects will be asked to provide numerical values on postoperative day 2.
measure: 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
timeFrame: Subjects will be asked to provide numerical values on postoperative day 3.
Secondary outcomes:
measure: Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home
timeFrame: Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)
measure: Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home
timeFrame: Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)
measure: Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3)
timeFrame: Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized)
measure: Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
timeFrame: Postoperative active voiding trial on postoperative day 1.
measure: Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.
timeFrame: Postoperatively up to day 3
measure: 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
timeFrame: Subjects will be asked to provide numerical value on postoperative day 3.
measure: 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
timeFrame: Subjects will be asked to provide numerical value on postoperative day 3.
measure: 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
timeFrame: Subjects will be asked to provide numerical value on postoperative day 3.
measure: 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
timeFrame: Subjects will be asked to provide numerical value on postoperative day 3.
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center (WRNMMC)
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center (WRNMMC)
name: Daniel Gruber, MD
role: STUDY_CHAIR
References:
citation: Dengler KL, Craig ER, DiCarlo-Meacham AM, Welch EK, Brooks DI, Vaccaro CM, Gruber DD. Preoperative pudendal block with liposomal and plain bupivacaine reduces pain associated with posterior colporrhaphy: a double-blinded, randomized controlled trial. Am J Obstet Gynecol. 2021 Nov;225(5):556.e1-556.e10. doi: 10.1016/j.ajog.2021.08.034. Epub 2021 Aug 30.