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

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain Management
• Intervention / Treatment: Drug: Exparel; Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel, Liposomal Bupivacaine; Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing	Drug: Exparel; Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
Active Comparator: Control; Subjects in this arm will receive 0.25% bupivacaine alone	Drug: Bupivacaine; 60cc Bupivacaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Matthew Kroh
• Investigators: Principal Investigator: Alisan Fathalizadeh, M.D, Staff

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 26, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 16-1571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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