Personalized Post-Operative Pain Management

Phase 4Active Not RecruitingNCT06669650

University of Tennessee Graduate School of Medicine208 enrolled

Overview

The main questions this study aims to answer are: Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery? Participants will: Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme. Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

208

Conditions

Persistent Post Operative Opioid Use Post-surgical Pain

Interventions

Patients in the intervention group will receive post operative opioid therapy based on their pharmacogenomic results. Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. Patients who are intermediate or normal CYP2D6 metabolizers with moderate or severe pain will receive oxycodone 5mg or oxycodone 10mg every 4 hours as needed respectively similar to the treatment offered to the control subjects. Normal or intermediate CYP2D6 metabolizers who are concomitantly taking a drug which is a strong CYP2D6 inducer will be treated as if they are in the rapid metabolizer group, and normal or intermediate patients that are concomitantly taking a drug which is a strong CYP2D6 inhibitor will be treated as if they were a poor metabolizer.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery. Exclusion Criteria: 1. \<18 years of age and \>85 years of age 2. Unable to understand study procedures. 3. Unwilling to give consent. 4. Patients with cognitive impairment that can affect their ability to give consent. 5. Previous Surgery \<14 days from time of enrollment. 6. Allergies to study intervention or oxycodone.

Outcomes

Primary Outcomes

Persistent Post-Operative Opioid Use

To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication

Time frame: 90 days

Secondary Outcomes

Post-Surgical Pain

To determine if PGx guided medication improves post-operative pain scores compared to similar patients who are given the standard current post operative opiate treatment. The scores are being rated using the Face, Legs, Activity, Cry and Consolability scale ranging from a minimum value of 0 to a maximum value of 10.

Time frame: 7 days