Personalized Post-Operative Pain Management

Phase 4

Active, not recruiting

• Conditions: Persistent Post Operative Opioid Use; Post-surgical Pain
• Interventions: Other: PGx guided personalized post-operative pain management; Drug: Oxycodone; Drug: Hydromorphone

• Registration Number: NCT06669650
• Lead Sponsor: University of Tennessee Graduate School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-25
• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard post-operative pain management (control)	PGx guided personalized post-operative pain management	Patients in the control groups will follow the current hospital standard of care and receive oxycodone 5mg every 4 hours as needed for moderate pain and oxycodone 10mg every four hours as needed for severe pain.
Standard post-operative pain management (control)	Oxycodone	Patients in the control groups will follow the current hospital standard of care and receive oxycodone 5mg every 4 hours as needed for moderate pain and oxycodone 10mg every four hours as needed for severe pain.
Pharmacogenomics (PGx) guided treatment (hydromorphone)	PGx guided personalized post-operative pain management	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.
Pharmacogenomics (PGx) guided treatment (hydromorphone)	Hydromorphone	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.

Primary Outcome Measures

Name	Time	Method
Persistent Post-Operative Opioid Use	90 days	To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication

Secondary Outcome Measures

Name	Time	Method
Post-Surgical Pain	7 days	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.

Trial Locations

Locations (1)

The University of Tennessee Graduate School of Medicine; 🇺🇸 Knoxville, Tennessee, United States