Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Primary Purpose
Post-operative Pain Management
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain Management
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
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exparel, Liposomal Bupivacaine
Control
Arm Description
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Subjects in this arm will receive 0.25% bupivacaine alone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03187379
Brief Title
Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Official Title
Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew Kroh
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel, Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive 0.25% bupivacaine alone
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Description
Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
60cc Bupivacaine
Primary Outcome Measure Information:
Title
Post-Operative Pain
Description
Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
Time Frame
24 hours post-surgery
Secondary Outcome Measure Information:
Title
Post-Operative Pain
Description
Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
Time Frame
48 hours post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alisan Fathalizadeh, M.D
Organizational Affiliation
Staff
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
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