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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Post-operative Pain
• Intervention / Treatment: Drug: Treatment with liposomal bupivacaine; Drug: Treatment with standard bupivacaine

Detailed Description

Use of liposomal bupivacaine has not been reported specifically for use in adolescent bariatric surgery. Our rationale is based on the notion that for most minimally invasive procedures, methods currently used for pain control provide good outcomes that liposomal bupivacaine may not necessarily be able to improve upon. It is critically important to minimize the narcotics for our bariatric surgical patients so they are mobilized early and frequently to minimize their risk for a deep venous thrombosis, which could become a pulmonary embolus. In addition, as these patients are prone to constipation after their operation as a result of their 2 week protein sparing liquid diet preoperatively, avoiding narcotics can reduce their chances of further challenges in return of their bowel function. For these reasons, we seek to investigate whether incorporating liposomal bupivacaine in the analgesic regimen for patients undergoing a laparoscopic sleeve gastrectomy will lead to improvements in patient-reported outcomes and decreased opioid utilization.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experiemental; Subjects will be treated with liposomal bupivacaine (study drug) after undergoing bariatric surgery.	Drug: Treatment with liposomal bupivacaine; Patients will randomly be treated with either liposomal bupivacaine (study drug) after undergoing bariatric surgery.; Other Names: Exparel
Active Comparator: Standard of Care; Subjects will be treated with standard bupivacaine after undergoing bariatric surgery.	Drug: Treatment with standard bupivacaine; Patients will randomly be treated with standard bupivacaine after undergoing bariatric surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative	Using the 10 point pain scale,determine if liposomal bupivacaine use leads to changed pain scores on post-operative days 0, 2, and 3 compared to standard analgesics after laparoscopic sleeve gastrectomy.	Days 0, 2, 3 post-operative
Changed use of opioid medications post operative days 0-3	To determine if liposomal bupivacaine use leads to changed total consumption of opioid medications after laparoscopic sleeve gastrectomy.	Post-operative days 0-3

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jason Sulkowski, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: liposomal bupivacaine; Exparel
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: HM20025041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No