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Local Analgesic

Bupivacaine-Meloxicam for Surgical Incisions

Phase 3
Recruiting
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
97 Previous Clinical Trials
53,462 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has bupivacaine-meloxicam been accepted by the FDA?

"The safety profile of bupivacaine-meloxicam was rated a 3 by the Power team, due to pre-existing clinical data that demonstrated its efficacy and robust evidence in favour of its security."

Answered by AI

Could you kindly provide information on the availability of enrollment in this investigation?

"According to clinicaltrials.gov, this research endeavour is no longer recruiting patients - it was initially posted on January 1st 2023 and last updated 18 days later. Nonetheless, there are currently 221 other trials seeking participants for their studies."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

What questions have other patients asked about this trial?

What kind of Side Effects??
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Seems like non of the Doctors in my area have very much research on the matter.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
2023. "Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05702827.
All > Vulvodynia
~56 spots leftby Apr 2025
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