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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-08-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bariatric Surgery Candidate Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will not be told the group to which they were assigned and will have been under anesthesia for administration. The surgeon, other clinical team members, and the study staff will not be blinded to the study group assignment.

Study Groups

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Experiemental

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

Group Type EXPERIMENTAL

Treatment with liposomal bupivacaine

Intervention Type DRUG

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

Standard of Care

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

Group Type ACTIVE_COMPARATOR

Treatment with standard bupivacaine

Intervention Type DRUG

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

Interventions

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Treatment with liposomal bupivacaine

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

Intervention Type DRUG

Treatment with standard bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No