Back to resultsPrecision Pain Management for Major Abdominal Surgery in Colorectal Surgery (PPaM)
Primary Purpose
Colorectal Cancer, Diverticular Disease, Crohn Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PGx-guided post-operative pain management
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Pain Management, Pharmacogenomics
Eligibility Criteria
Inclusion Criteria:
- Subject capable of giving consent
- Age 18-80
- Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)
Exclusion Criteria:
- Patient does not speak English
- Patient with substance-use disorder (including alcohol)
- Patient diagnosed with major depression
- Patient currently taking opioids
- Previous long-term opioid use (> 3 months)
- Previous opioid use with a dose of >100 milligram morphine equivalent (MME)
- Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)
- Documented allergy to pain medication
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
PGx-guided
Arm Description
The control arm will receive no intervention and will follow standard of care for post-operative pain management.
The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.
Outcomes
Primary Outcome Measures
Post-operative opioid use
Post-operative opioid use through visual analog scale guided administration of narcotic equivalent
Overall Benefit of Analgesia Score (OBAS)
Secondary Outcome Measures
Length of stay
Readmission rate
Functional status
Assessed through Duke Activity Status Index (DASI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03455751
Brief Title
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
Acronym
PPaM
Official Title
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Failed to meet enrollment goals
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
January 9, 2019 (Actual)
Study Completion Date
January 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Diverticular Disease, Crohn Disease, Ulcerative Colitis
Keywords
Pain Management, Pharmacogenomics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm will receive no intervention and will follow standard of care for post-operative pain management.
Arm Title
PGx-guided
Arm Type
Experimental
Arm Description
The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.
Intervention Type
Genetic
Intervention Name(s)
PGx-guided post-operative pain management
Intervention Description
Post-operative pain management as indicated by pharmacogenomic testing results.
Primary Outcome Measure Information:
Title
Post-operative opioid use
Description
Post-operative opioid use through visual analog scale guided administration of narcotic equivalent
Time Frame
Post-op day 1
Title
Overall Benefit of Analgesia Score (OBAS)
Time Frame
Post-op day 1
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
30 days
Title
Readmission rate
Time Frame
30 days
Title
Functional status
Description
Assessed through Duke Activity Status Index (DASI)
Time Frame
4 weeks and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject capable of giving consent
Age 18-80
Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)
Exclusion Criteria:
Patient does not speak English
Patient with substance-use disorder (including alcohol)
Patient diagnosed with major depression
Patient currently taking opioids
Previous long-term opioid use (> 3 months)
Previous opioid use with a dose of >100 milligram morphine equivalent (MME)
Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)
Documented allergy to pain medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Liska, MD
Organizational Affiliation
The Cleveland Clinic
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
Learn more about this trial
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
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