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

Primary Purpose

Bariatric Surgery Candidate, Post-operative Pain

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment with liposomal bupivacaine
Treatment with standard bupivacaine
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring liposomal bupivacaine, Exparel

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experiemental

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 4, 2023
Last Updated
October 12, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT06077214
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Post-operative Pain
Keywords
liposomal bupivacaine, Exparel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Patients will randomly be treated with either liposomal bupivacaine (study drug) or standard bupivacaine after undergoing bariatric surgery.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiemental
Arm Type
Experimental
Arm Description
Subjects will be treated with liposomal bupivacaine (study drug) after undergoing bariatric surgery.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Subjects will be treated with standard bupivacaine after undergoing bariatric surgery.
Intervention Type
Drug
Intervention Name(s)
Treatment with liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Patients will randomly be treated with either liposomal bupivacaine (study drug) after undergoing bariatric surgery.
Intervention Type
Drug
Intervention Name(s)
Treatment with standard bupivacaine
Intervention Description
Patients will randomly be treated with standard bupivacaine after undergoing bariatric surgery.
Primary Outcome Measure Information:
Title
Changed pain scores using liposomal bupivacaine day 1 post-operative
Description
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.
Time Frame
Day 1 post-operative
Secondary Outcome Measure Information:
Title
Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative
Description
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.
Time Frame
Days 0, 2, 3 post-operative
Title
Changed use of opioid medications post operative days 0-3
Description
To determine if liposomal bupivacaine use leads to changed total consumption of opioid medications after laparoscopic sleeve gastrectomy.
Time Frame
Post-operative days 0-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Sulkowski
Phone
804-828-3500
Email
jason.sulkowski@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Lanning
Phone
804-828-3500
Email
david.lanning@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Sulkowski
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Sulkowski
Phone
804-828-3500
Email
jason.sulkowski@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
David Lanning
Phone
804-828-3500
Email
david.lanning@vcuhealth.org

12. IPD Sharing Statement

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

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