Your session is about to expire
← Back to Search
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)
Must not have
Long acting opioids within 3 days
Any opioids within 24h
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post surgery
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing a combination of two pain-relief drugs applied directly to the surgical site in patients having a specific type of urinary incontinence surgery. The goal is to see if this combination can reduce pain and the need for narcotic painkillers.
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.
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.
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 belowSelect...
English is my first language.
Select...
I am having surgery to support my bladder or urethra.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken long-acting opioids in the last 3 days.
Select...
I have not taken any opioids in the last 24 hours.
Select...
I am unable to give consent for my own medical treatment.
Select...
I am having or have had surgery for pelvic organ prolapse or related conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery
Secondary study objectives
Compare average pain on each day post operatively
Compare satisfaction with pain control post operatively
Compare worst pain on each day post operatively
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Vulvodynia, such as local anesthetics and NSAIDs, work through different mechanisms to alleviate pain. Local anesthetics like bupivacaine block nerve signals, preventing the transmission of pain to the brain.
NSAIDs like meloxicam inhibit COX enzymes, reducing inflammation and associated pain. These treatments are significant for Vulvodynia patients as they address both nerve-related and inflammatory pain, offering a more comprehensive approach to pain management.
[Subarachnoid meloxicam does not inhibit the mechanical hypernociception on carrageenan test in rats].Behavioural assessment of the effects of tumour growth in rats and the influence of the analgesics carprofen and meloxicam.Systemic meloxicam reduces tactile allodynia development after L5 single spinal nerve injury in rats.
[Subarachnoid meloxicam does not inhibit the mechanical hypernociception on carrageenan test in rats].Behavioural assessment of the effects of tumour growth in rats and the influence of the analgesics carprofen and meloxicam.Systemic meloxicam reduces tactile allodynia development after L5 single spinal nerve injury in rats.
Find a Location
Who is running the clinical trial?
TriHealth Inc.Lead Sponsor
98 Previous Clinical Trials
53,615 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- English is my first language.I haven't taken long-acting opioids in the last 3 days.I have not taken steroids in the last 10 days.You have been taking opioid pain medication every day for the past 3 months.I have not taken any opioids in the last 24 hours.I am unable to give consent for my own medical treatment.You are allergic to meloxicam or bupivacaine.I haven't taken NSAIDs in the week before my surgery.I am having surgery to support my bladder or urethra.I am having or have had surgery for pelvic organ prolapse or related conditions.
Research Study Groups:
This trial has the following groups:- Group 1: bupivacaine-meloxicam
- Group 2: Standard of Care
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger