Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler

Phase 4

Completed

• Conditions: Post-operative Pain Management
• Interventions: Drug: Bupivacaine; Drug: Exparel

• Registration Number: NCT03187379
• Lead Sponsor: Matthew Kroh

Brief Summary

This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine injection solution) injections intra-operatively at time of incision site closure. The control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of incision site closure. The medication for the control group is our current standard of care. The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours a member of the research team will administer a 2-part questionnaire containing the VAS and the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is validated for assessment of the patient's experience of pain and it hindrance to daily activity in the post operative period.

Detailed Description

The study will include up to 150 patients, and will consist of two cohort. The study cohort will include 75 patients who receive intraoperative Exparel® injections at the incision locations in addition to our standard multimodality post-operative analgesia. The control arm will include 75 patients who meet inclusion criteria but receive standard 0.25% bupivacaine and our standard multimodality post-operative analgesia. Patients will be randomized by REDCap™ database system in collaboration with Cleveland Clinic Pharmacy to receive either Exparel® or the control medication (0.25% Bupivacaine). Consent from patients will be obtained and documented by a dedicated research personnel prior to any enrollment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Primary Completion: 2021-01-26
• Study Completion: 2021-02-01
• Results First Submitted: 2022-04-27
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Results First Posted: 2022-06-21
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• bariatric surgery patients
• laparoscopic roux-en-y gastric bypass
• use of EEA stapler anastomosis

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Exclusion Criteria

• age <18 years
• previous history of roux-en-y gastric bypass
• patients undergoing other bariatric procedures
• pre-operative opioid analgesics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Bupivacaine	Subjects in this arm will receive 0.25% bupivacaine alone
Exparel, Liposomal Bupivacaine	Exparel	Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

Primary Outcome Measures

Name	Time	Method
Post-Operative Pain	24 hours post-surgery	Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.

Secondary Outcome Measures

Name	Time	Method
Post-Operative Pain	48 hours post-surgery	Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States