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

NCT05702827 | Completed Phase 3 FDA Drug

• 1 other identifier: 22-102
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress Urinary Incontinence; Surgical Incision; Pain Vulva

Outcome Measures

Primary Outcomes (1)

• To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery

  Pain medication diary

  72 hours post surgery

Secondary Outcomes (3)

• Compare average pain on each day post operatively

  72 hours post surgery

• Compare worst pain on each day post operatively

  72 hours post surgery

• Compare satisfaction with pain control post operatively

  72 hours post surgery

Study Arms (2)

bupivacaine-meloxicam

EXPERIMENTAL

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

Drug: Bupivacaine-Meloxicam

Standard of Care

NO INTERVENTION

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.

Interventions

Bupivacaine-Meloxicam DRUG

All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.

bupivacaine-meloxicam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (2)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Surgical Wound; Vulvodynia

Interventions

bupivacaine-meloxicam drug combination

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Vulvar Diseases; Genital Diseases, Female; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: January 23, 2023
• Primary Completion: March 22, 2024
• Study Completion: April 18, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)