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TAP Block with Liposomal Bupivacaine for Post-Surgery Pain in Obesity (TAP Trial)
Phase 1
Recruiting
Led By Abdelrahman Nimeri, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hours,12, 48, and 72
Awards & highlights
TAP Trial Summary
This trial is investigating whether a cheaper local anesthetic is just as effective as a more expensive one for pain relief after surgery.
Who is the study for?
This trial is for adults over 18 who are about to have their first sleeve gastrectomy or gastric bypass surgery for obesity. They must be able to consent and follow study procedures. It's not for those having additional hernia repairs, chronic opioid users, or duodenal switch surgeries.Check my eligibility
What is being tested?
The study compares two types of pain relief injections after bariatric surgery: plain bupivacaine versus liposomal bupivacaine. The goal is to see if they're equally effective in managing pain and patient satisfaction while potentially reducing costs.See study design
What are the potential side effects?
Possible side effects from the injections may include discomfort at the injection site, nausea, dizziness, headaches, or allergic reactions. These can vary based on individual tolerance and reaction to the medication.
TAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hours,12, 48, and 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hours,12, 48, and 72
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24 Hour Visual Analogue Scale (VAS) Pain Score
Secondary outcome measures
Length of Hospital Stay
Morphine Equivalences - Immediate
Morphine Equivalences - Week 1
+3 moreTAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal BupivacaineExperimental Treatment1 Intervention
Study group patients will receive Transversus Abdominis Plane (TAP) block with a Liposomal Bupivacaine mixture, containing 20 mL Liposomal Bupivacaine, 30 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
Group II: Bupivacaine onlyActive Control1 Intervention
Active control group patients receive Transversus Abdominis Plane (TAP) block with a Bupivacaine only mixture, containing 50 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,025 Total Patients Enrolled
38 Trials studying Obesity
5,747 Patients Enrolled for Obesity
Abdelrahman Nimeri, MDPrincipal InvestigatorWake Forest University Health Sciences, Atrium Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having a duodenal switch surgery.I am having surgery for weight loss and also for a hernia or gallbladder at the same time.I am older than 18 years.I am having a sleeve gastrectomy or gastric bypass surgery.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal Bupivacaine
- Group 2: Bupivacaine only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Liposomal bupivacaine been sanctioned by the FDA?
"Currently, the safety of Liposomal bupivacaine has been assessed with a score of 1. This is due to it being an early Phase 1 trial, which has only yielded limited data on its efficacy and overall security."
Answered by AI
Are there still enrollment opportunities for prospective participants in this experiment?
"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting patients; the trial was first published on November 29th 2022 and has been updated since then. In total, 212 participants are required at one site for completion of the study."
Answered by AI
How many participants are eligible to enter this medical experiment?
"Affirmative, the clinicaltrial.gov database implies that this clinical trial is currently seeking participants. The protocol was initially published on November 29th 2022 and has been revised since then; 212 patients are required for a single location to fulfil its objectives."
Answered by AI
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