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

TriHealth

Status and phase: Completed; Phase 3

Conditions: Stress Urinary Incontinence; Surgical Incision; Pain Vulva

Treatments: Drug: Bupivacaine-Meloxicam

Study type: Interventional

Funder types: Other

Identifiers

NCT05702827

22-102

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

bupivacaine-meloxicam

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine-Meloxicam

Standard of Care

No Intervention group

Description:

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.