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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2024-04-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence Surgical Incision Pain Vulva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Bupivacaine-Meloxicam

Intervention Type DRUG

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

Standard of Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacaine-Meloxicam

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No