NCT06669650

Personalized Post-Operative Pain Management

Personalized Post-Operative Opiate Prescriptions Based on Pharmacogenetics of CytochromeP450, COMT, and OPRM1

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: University of Tennessee Graduate School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Persistent Post Operative Opioid Use
• Post-surgical Pain

Interventions

Type	Name	Description
OTHER	PGx guided personalized post-operative pain management	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.
DRUG	Oxycodone	oxycodone
DRUG	Hydromorphone	hydromorphone

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study