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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 1

Conditions: Post-operative Pain; Bariatric Surgery Candidate

Treatments: Drug: Treatment with standard bupivacaine; Drug: Treatment with liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06077214

HM20025041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Experiemental

Experimental group

Description:

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

Treatment:

Drug: Treatment with liposomal bupivacaine

Standard of Care

Active Comparator group

Description:

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

Treatment:

Drug: Treatment with standard bupivacaine