Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

NCT03455751 | Terminated

• 1 other identifier: 17-1540
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Diverticular Disease; Crohn Disease; Ulcerative Colitis

Keywords

Pain Management; Pharmacogenomics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Length of stay

  30 days

• Readmission rate

  30 days

• Functional status

  4 weeks and 3 months

Study Arms (2)

Control

NO INTERVENTION

The control arm will receive no intervention and will follow standard of care for post-operative pain management.

PGx-guided

EXPERIMENTAL

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

Interventions

PGx-guided post-operative pain management GENETIC

Post-operative pain management as indicated by pharmacogenomic testing results.

PGx-guided

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticular Diseases; Crohn Disease; Colitis, Ulcerative; Agnosia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Liska, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff, Colorectal Surgery

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 7, 2018
• Study Start: April 17, 2018
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

US (1)