Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

Study Overview
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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.

Official Title
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Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

Conditions
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Colorectal Cancer, Diverticular Disease, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Genetic: PGx-guided post-operative pain management


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control arm will receive no intervention and will follow standard of care for post-operative pain management. | |
| Experimental: PGx-guided<br>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<br>* Post-operative pain management as indicated by pharmacogenomic testing results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Management, Pharmacogenomics