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

NCT ID: NCT03187379

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2021-02-01

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.

Conditions

Post-operative Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine

Control

Subjects in this arm will receive 0.25% bupivacaine alone

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

60cc Bupivacaine

Interventions

Exparel

Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine

Intervention Type: DRUG

Bupivacaine

60cc Bupivacaine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matthew Kroh

OTHER

Sponsor Role: lead

Responsible Party

Matthew Kroh

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alisan Fathalizadeh, M.D

Role: PRINCIPAL_INVESTIGATOR

Staff

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

16-1571

Identifier Type: -

Identifier Source: org_study_id