Clinical trial NCT06077214: Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients
Official title: Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bariatric Surgery Candidate
Post-operative Pain
Keywords: liposomal bupivacaine
Exparel
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 9
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will randomly be treated with either liposomal bupivacaine (study drug) or standard bupivacaine after undergoing bariatric surgery.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changed pain scores using liposomal bupivacaine day 1 post-operative
timeFrame: Day 1 post-operative
Secondary outcomes:
measure: Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative
timeFrame: Days 0, 2, 3 post-operative
measure: Changed use of opioid medications post operative days 0-3
timeFrame: Post-operative days 0-3
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jason Sulkowski
role: PRINCIPAL_INVESTIGATOR
References: