Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

Not Applicable

Terminated

• Conditions: Colorectal Cancer; Diverticular Disease; Crohn Disease; Ulcerative Colitis
• Interventions: Genetic: PGx-guided post-operative pain management

• Registration Number: NCT03455751
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-07
• Study Start: 2018-04-17
• Primary Completion: 2019-01-09
• Study Completion: 2019-01-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGx-guided	PGx-guided post-operative pain management	The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States