Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

NCT ID: NCT03455751

Last Updated: 2019-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2019-01-09

Brief Summary

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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

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Conditions

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Colorectal Cancer Diverticular Disease Crohn Disease Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

PGx-guided

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

Group Type EXPERIMENTAL

PGx-guided post-operative pain management

Intervention Type GENETIC

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

Interventions

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PGx-guided post-operative pain management

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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David Liska

Associate Staff, Colorectal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Liska, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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17-1540

Identifier Type: -

Identifier Source: org_study_id

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