drugset / Trial / NCT06669650

Personalized Post-Operative Pain Management

NCT06669650

Phase 4 Active not recruiting 208 enrolled University of Tennessee Graduate School of Medicine
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2024-09-25
Primary completion
2025-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 2 mg Oral
Subject Hydromorphone Other / unclassified 4 mg Oral
Comparator Oxycodone Other / unclassified 5 mg
Comparator Oxycodone Other / unclassified 10 mg

Indications