Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery (PPaM)

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Crohn Disease; Ulcerative Colitis; Diverticular Disease
• Intervention / Treatment: Genetic: PGx-guided post-operative pain management

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control arm will receive no intervention and will follow standard of care for post-operative pain management.
Experimental: PGx-guided; The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.	Genetic: PGx-guided post-operative pain management; Post-operative pain management as indicated by pharmacogenomic testing results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative opioid use	Post-operative opioid use through visual analog scale guided administration of narcotic equivalent	Post-op day 1
Overall Benefit of Analgesia Score (OBAS)		Post-op day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay		30 days
Readmission rate		30 days
Functional status	Assessed through Duke Activity Status Index (DASI)	4 weeks and 3 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: David Liska, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): January 9, 2019
• Study Completion (Actual): January 9, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pharmacogenomics; Pain Management
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Crohn Disease; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: 17-1540

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No