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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077214
• Other study ID #: HM20025041
• Status: Recruiting
• Phase: Phase 1
• Start date: January 31, 2023
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Virginia Commonwealth University
• Contact: Jason Sulkowski
• Phone: 804-828-3500
• Email: jason.sulkowski[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Treatment with liposomal bupivacaine
Patients will randomly be treated with either liposomal bupivacaine (study drug) after undergoing bariatric surgery.
• Treatment with standard bupivacaine
Patients will randomly be treated with standard bupivacaine after undergoing bariatric surgery.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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