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

Study Overview
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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.

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

Conditions
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Stress Urinary Incontinence, Surgical Incision, Pain Vulva

Intervention / Treatment
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* Drug: Bupivacaine-Meloxicam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupivacaine-meloxicam<br>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<br>* All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.<br>|
| No Intervention: Standard of Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare average pain on each day post operatively | 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 | 72 hours post surgery | 
| Compare worst pain on each day post operatively | 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 | 72 hours post surgery | 
| Compare satisfaction with pain control post operatively | 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 | 72 hours post surgery |