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Long-Lasting Pain Relief for Postoperative Pain in Bariatric Surgery

Phase 1

Recruiting

Led By Jason Sulkowski

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are undergoing a laparoscopic sleeve gastrectomy for severe obesity and are between 13 and 2018 years of age

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0, 2, 3 post-operative

Awards & highlights

Study Summary

This trial shows a new form of local analgesic that can last longer, up to 72 hours, and can help with post-operative incisional pain.

Who is the study for?

This trial is for teens (13-2018 years old) with severe obesity undergoing laparoscopic sleeve gastrectomy at the Children's Hospital of Richmond at VCU. Participants must understand English or Spanish and not have allergies to bupivacaine.Check my eligibility

What is being tested?

The study compares liposomal bupivacaine, which may control pain up to 72 hours, with standard bupivacaine that works up to 6 hours. It aims to see if the longer-lasting formula better matches the time when post-surgery pain is highest.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site, such as swelling or discomfort, possible nerve damage leading to numbness or weakness, and rare but serious heart or breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 13 and 2018 years old and scheduled for a weight loss surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0, 2, 3 post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 0, 2, 3 post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 2, 3 post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changed pain scores using liposomal bupivacaine day 1 post-operative

Secondary outcome measures

Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative

Changed use of opioid medications post operative days 0-3

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperiementalExperimental Treatment1 Intervention

Subjects will be treated with liposomal bupivacaine (study drug) after undergoing bariatric surgery.

Group II: Standard of CareActive Control1 Intervention

Subjects will be treated with standard bupivacaine after undergoing bariatric surgery.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,884,995 Total Patients Enrolled

Jason SulkowskiPrincipal InvestigatorVirginia Commonwealth University

Frequently Asked Questions

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

Are individuals still able to participate in this particular research endeavor?

"The data posted on clinicaltrials.gov validates that this medical study is actively recruiting prospective participants. This particular trial was initially listed on January 31st 2023 and most recently updated in October 4th, 2023."

Answered by AI

What criteria must an individual fulfill in order to take part in this research endeavor?

"This research endeavour is currently seeking 50 minors, aged between 13 and 18 years old, who are eligible for bariatric surgery."

Answered by AI

Are persons aged 80 and above being accepted for enrollment in this trial?

"To qualify for this study, potential participants must range between the ages of 13 and 18. The same source indicates there are 73 trials welcoming patients under 18 years old and 451 studies with eligibility criteria set above 65."

Answered by AI

To what degree does Experimental pose a risk to human health?

"Our team at Power has determined that Experimental carries a low risk, rating it as 1 on the safety scale due to its status of being in Phase 1 - meaning there is only minimal data regarding efficacy and safety."

Answered by AI

How many people are enrolled in this experiment?

"Indeed, the data available on clinicaltrials.gov indicates that this medical study is still recruiting patients. It was initiated on January 31st 2023 and last amended on October 4th 2023 with a goal of including 50 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients

2023. "Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077214.