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

NCT06077214 | Completed Phase 1 FDA Drug

• 1 other identifier: HM20025041
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

liposomal bupivacaine; Exparel

Outcome Measures

Primary Outcomes (1)

• Changed pain scores using liposomal bupivacaine day 1 post-operative

  Using the 10 point pain scale, determine if liposomal bupivacaine use leads to changed pain scores on post-operative day 1 compared to standard analgesics after laparoscopic sleeve gastrectomy.

  Day 1 post-operative

Secondary Outcomes (2)

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

  Days 0, 2, 3 post-operative

• Changed use of opioid medications post operative days 0-3

  Post-operative days 0-3

Study Arms (2)

Experiemental

EXPERIMENTAL

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

Drug: Treatment with liposomal bupivacaine

Standard of Care

ACTIVE COMPARATOR

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

Drug: Treatment with standard bupivacaine

Interventions

Treatment with liposomal bupivacaine DRUG

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

Also known as: Exparel

Experiemental

Treatment with standard bupivacaine DRUG

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

Standard of Care

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients who are undergoing a laparoscopic sleeve gastrectomy for severe obesity who are between 13 and 2018 years of age.
• Only patients treated at the Children's Hospital of Richmond at VCU will be included.

You may not qualify if:

• patients less than 13 or greater than 2018 years of age
• patients with an allergy to bupivacaine
• any patients undergoing any additional procedures at the time of the laparoscopic sleeve gastrectomy.
• English or Spanish proficiency will be necessary.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jason Sulkowski

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be told the group to which they were assigned and will have been under anesthesia for administration. The surgeon, other clinical team members, and the study staff will not be blinded to the study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will randomly be treated with either liposomal bupivacaine (study drug) or standard bupivacaine after undergoing bariatric surgery.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: January 31, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

US (1)