PPaM: Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03455751
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Diverticular Disease; Crohn Disease; Ulcerative Colitis	Genetic: PGx-guided post-operative pain management	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
• Actual Study Start Date: Apr 17, 2018
• Actual Primary Completion Date: Jan 9, 2019
• Actual Study Completion Date: Jan 9, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Post-operative opioid use [Post-op day 1]

   Post-operative opioid use through visual analog scale guided administration of narcotic equivalent

2. Overall Benefit of Analgesia Score (OBAS) [Post-op day 1]

Secondary Outcome Measures

1. Length of stay [30 days]

2. Readmission rate [30 days]

3. Functional status [4 weeks and 3 months]

   Assessed through Duke Activity Status Index (DASI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Liska, Associate Staff, Colorectal Surgery, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03455751
• Other Study ID Numbers: 17-1540
• First Posted: Mar 7, 2018
• Last Update Posted: Mar 18, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Liska, Associate Staff, Colorectal Surgery, The Cleveland Clinic: Pain Management; Pharmacogenomics
• Additional relevant MeSH terms: Crohn Disease; Diverticular Diseases; Diverticulum

Study Results

No Results Posted as of Mar 18, 2019