Phase 2 N=120 Randomized Triple-blind Treatment

Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT04032327 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: 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 — 2; 0 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Exparel plus plain bupivacaine (Drug); Bupivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Walter Reed National Military Medical Center
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	3; 2	—
PRIMARY 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	3; 2	—
PRIMARY 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	3; 2	—
SECONDARY Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home	3600; 2400	—
SECONDARY Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home	4000; 3250	—
SECONDARY Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3)	45.0; 57.1	—
SECONDARY Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.	82; 72	—
SECONDARY Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.	71.6; 73.3	—
SECONDARY 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	3.5; 3	—
SECONDARY 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	0.500; 1	—
SECONDARY 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	1; 1	—
SECONDARY 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	0; 1	—

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.

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Data sourced from ClinicalTrials.gov (NCT04032327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.