Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03455751

Acronym

PPaM

Enrollment

Registered

2018-03-07

Start date

2018-04-17

Completion date

2019-01-09

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Crohn Disease, Diverticular Disease, Ulcerative Colitis

Keywords

Pain Management, Pharmacogenomics

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.

Interventions

GENETICPGx-guided post-operative pain management

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026