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Local Analgesic

Bupivacaine-Meloxicam for Surgical Incisions

Phase 3
Waitlist Available
Research Sponsored by TriHealth Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English as first language
Undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post surgery
Awards & highlights

Study Summary

This trial compares local anesthetics and painkillers to see if they reduce pain and narcotic use during surgery.

Who is the study for?
This trial is for English-speaking patients having retropubic mid-urethral sling surgery, possibly with anterior or urethrocele repair. It's not for those getting additional surgeries like hysterectomy, can't consent, are allergic to the study drugs, pregnant/breastfeeding, recently used steroids or various painkillers.Check my eligibility
What is being tested?
The study tests a combined local anesthetic (Bupivacaine-meloxicam) on abdominal incisions in sling surgery patients. It aims to see if this reduces the need for narcotics and lessens pain compared to current practices.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as swelling or itching, possible nerve damage risks associated with injections near nerves, and typical drug-related issues like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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English is my first language.
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I am having surgery to support my bladder or urethra.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery
Secondary outcome measures
Compare average pain on each day post operatively
Compare satisfaction with pain control post operatively
Compare worst pain on each day post operatively

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: bupivacaine-meloxicamExperimental Treatment1 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. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group
Group II: Standard of CareActive Control1 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.

Find a Location

Who is running the clinical trial?

TriHealth Inc.Lead Sponsor
98 Previous Clinical Trials
53,615 Total Patients Enrolled

Media Library

Bupivacaine-Meloxicam (Local Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05702827 — Phase 3
Vulvodynia Research Study Groups: bupivacaine-meloxicam, Standard of Care
Vulvodynia Clinical Trial 2023: Bupivacaine-Meloxicam Highlights & Side Effects. Trial Name: NCT05702827 — Phase 3
Bupivacaine-Meloxicam (Local Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05702827 — Phase 3
~54 spots leftby Jun 2025
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