What side effects are associated with this type of intervention?

The use of bupivacaine, a local anesthetic, in the Transversus Abdominis Plane (TAP) block for obesity treatment can lead to side effects such as local anesthetic systemic toxicity (LAST), which includes symptoms like tinnitus, dizziness, seizures, and cardiac arrhythmias. Localized side effects may include pain at the injection site, infection, and transient neurological symptoms. Broader obesity treatments, such as medications and bariatric surgery, can have side effects ranging from gastrointestinal issues to surgical risks.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and semaglutide. These medications work through various mechanisms such as appetite suppression, increased satiety, and reduced fat absorption. While bupivacaine is a local anesthetic used for pain management in surgical procedures, it is not approved for the treatment of obesity.

What other types of research exist?

Promising alternatives to Bupivacaine for obesity patients in 2024 include liposomal bupivacaine, which offers prolonged pain relief, and multimodal analgesia strategies that incorporate medications like dexmedetomidine to enhance postoperative analgesia and recovery.

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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

No Placebo-Only Group

Summary

This trial compares two types of pain relief for patients having weight-loss surgery. One uses standard medication, and the other uses a longer-lasting version. Both block pain signals, but the long-lasting one might reduce the need for extra painkillers.

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and hours,12, 48, and 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24 Hour Visual Analogue Scale (VAS) Pain Score

Secondary study objectives

Length of Hospital Stay

Morphine Equivalences - Immediate

Morphine Equivalences - Week 1

+3 more

Awards & Highlights

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: 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

Do I qualify?Apply below to find out

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 obesity include lifestyle interventions, pharmacologic therapies, and surgical procedures. Lifestyle interventions focus on diet, exercise, and behavioral changes to reduce caloric intake and increase energy expenditure. Pharmacologic treatments often involve medications that suppress appetite, reduce fat absorption, or increase energy expenditure. Surgical options, such as bariatric surgery, physically alter the digestive system to limit food intake and nutrient absorption. In the context of pain management for obesity-related surgeries, local anesthetics like bupivacaine are used to block nerve signals in specific areas, such as the Transversus Abdominis Plane, to reduce postoperative pain. This is crucial for obesity patients as effective pain management can enhance recovery, reduce the need for opioids, and minimize complications associated with surgery.

A randomized trial of bupivicaine pain pumps to eliminate the need for patient controlled analgesia pumps in primary laparoscopic Roux-en-Y gastric bypass.