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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
Must not have
Patients undergoing any additional procedures at the time of the laparoscopic sleeve gastrectomy
Patients less than 13 or greater than 2018 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 2, 3 post-operative
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am having other surgeries in addition to the sleeve gastrectomy.
Select...
This criterion seems to contain a typo regarding age.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changed pain scores using liposomal bupivacaine day 1 post-operative
Secondary study objectives
Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative
Changed use of opioid medications post operative days 0-3

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: 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.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
719 Previous Clinical Trials
22,895,786 Total Patients Enrolled
Jason SulkowskiPrincipal InvestigatorVirginia Commonwealth University
~2 spots leftby Feb 2025
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