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

NCT03187379 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-1571
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-Operative Pain

  48 hours post-surgery

Study Arms (2)

Exparel, Liposomal Bupivacaine

EXPERIMENTAL

Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

Drug: Exparel

Control

ACTIVE COMPARATOR

Subjects in this arm will receive 0.25% bupivacaine alone

Drug: Bupivacaine

Interventions

Exparel DRUG

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

Exparel, Liposomal Bupivacaine

Bupivacaine DRUG

60cc Bupivacaine

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Matthew Kroh: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Matthew Kroh
• Organization: Cleveland Clinic Foundation

krohm@ccf.org

12164457410

Study Officials

• Alisan Fathalizadeh, M.D

  Staff

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 14, 2017
• Study Start: June 1, 2017
• Primary Completion: January 26, 2021
• Study Completion: February 1, 2021
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)