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Completed

NCT Number: NCT06077214

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment with liposomal bupivacaine

Drug

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

Other names: Exparel

Treatment with standard bupivacaine

Drug

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Changed use of opioid medications post operative days 0-3

    Time frame: Post-operative days 0-3

    To determine if liposomal bupivacaine use leads to changed total consumption of opioid medications after laparoscopic sleeve gastrectomy.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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