Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT06669650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Post-Operative Pain Management
Sponsor:
University of Tennessee Graduate School of Medicine
Organization:
Study Overview
Official Title:
Personalized Post-Operative Opiate Prescriptions Based on Pharmacogenetics of CytochromeP450, COMT, and OPRM1
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CORNET Award | OTHER_GRANT | The University of Tennessee Graduate School of Medicine | View |