Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery

Phase 3

Completed

• Conditions: Stress Urinary Incontinence; Surgical Incision; Pain Vulva
• Interventions: Drug: Bupivacaine-Meloxicam

• Registration Number: NCT05702827
• Lead Sponsor: TriHealth Inc.

Brief Summary

This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study Start: 2023-01-23
• Study First Posted: 2023-01-27
• Primary Completion: 2024-03-22
• Study Completion: 2024-04-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

• undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)
• English as first language

Exclusion Criteria

• patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy
• NSAID use within 7 days of surgery
• steroid use within 10 days
• daily opioid use in the last 3 months
• long acting opioids within 3 days
• any opioids within 24h
• patients unable to consent for themselves
• patients allergic to meloxicam or bupivacaine
• pregnant or lactating patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine-meloxicam	Bupivacaine-Meloxicam	All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group

Primary Outcome Measures

Name	Time	Method
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery	72 hours post surgery	Pain medication diary

Secondary Outcome Measures

Name	Time	Method
Compare worst pain on each day post operatively	72 hours post surgery	11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3
Compare average pain on each day post operatively	72 hours post surgery	11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3
Compare satisfaction with pain control post operatively	72 hours post surgery	11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3

Trial Locations

Locations (2)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States

Trihealth (Good Samaritan Hospital, Bethesda North Hospital); 🇺🇸 Cincinnati, Ohio, United States