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


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Verified June 2017 by John Rodriguez, MD, The Cleveland Clinic

Sponsor:

Information provided by (Responsible Party):

John Rodriguez, MD, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT03187379

First received: June 1, 2017

Last updated: June 12, 2017

Last verified: June 2017

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.

Post-operative Pain Management Drug: Exparel
Drug: Bupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 150
Actual Study Start Date: June 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03187379

Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Linda Libertini    216-445-4148    libertl@ccf.org   

The Cleveland Clinic

Principal Investigator: John Rodriguez, MD The Cleveland Clinic

Responsible Party: John Rodriguez, MD, Associate Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03187379     History of Changes
Other Study ID Numbers: 16-1571
Study First Received: June 1, 2017
Last Updated: June 12, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:

Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 14, 2017