Personalized Post-Operative Pain Management

University of Tennessee Graduate School of Medicine

Status and phase: Active, not recruiting; Phase 4

Conditions: Post-surgical Pain; Persistent Post Operative Opioid Use

Treatments: Other: PGx guided personalized post-operative pain management; Drug: Hydromorphone; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT06669650

5226

CORNET Award (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

208 participants in 2 patient groups

Standard post-operative pain management (control)

Active Comparator group

Description:

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.

Treatment:

Drug: Oxycodone

Other: PGx guided personalized post-operative pain management

Pharmacogenomics (PGx) guided treatment (hydromorphone)

Experimental group

Description:

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.

Treatment:

Drug: Hydromorphone

Other: PGx guided personalized post-operative pain management