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

NCT06077214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-03-07

No results posted yet for this study

Summary

Liposomal bupivacaine (trade name Exparel) is a local analgesic that is designed to produce more long-term pain control. Bupivacaine, a widely used local analgesic, is stored within liposomes, which break down in soft tissue over time. Typical length of therapeutic effect for standard bupivacaine is up to 6 hours. The liposomal formulation of bupivacaine, however, has a length of therapeutic effect of up to 72 hours. Typical post-operative incisional pain is known to last for several days in most cases and is thought to peak between 1-2 days after surgery. Therefore, the benefit of most short-acting local analgesics does not overlap with the period of most need.

Conditions

  • Bariatric Surgery Candidate
  • Post-operative Pain

Interventions

DRUG

Treatment with liposomal bupivacaine

Patients will randomly be treated with either liposomal bupivacaine (study drug) after undergoing bariatric surgery.

DRUG

Treatment with standard bupivacaine

Patients will randomly be treated with standard bupivacaine after undergoing bariatric surgery.

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Jason Sulkowski · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-08-20
Completion
2024-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06077214 on ClinicalTrials.gov