Personalized Post-Operative Pain Management

NCT ID: NCT06669650

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2025-12-31

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.

Conditions

Persistent Post Operative Opioid Use; Post-surgical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard post-operative pain management (control)

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.

Group Type: ACTIVE_COMPARATOR

PGx guided personalized post-operative pain management

Intervention Type: OTHER

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.

Oxycodone

Intervention Type: DRUG

oxycodone

Pharmacogenomics (PGx) guided treatment (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.

Group Type: EXPERIMENTAL

PGx guided personalized post-operative pain management

Intervention Type: OTHER

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.

Hydromorphone

Intervention Type: DRUG

hydromorphone

Interventions

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.

Intervention Type: OTHER

Oxycodone

oxycodone

Intervention Type: DRUG

Hydromorphone

hydromorphone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Trey Henderson

Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

CORNET Award

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5226

Identifier Type: -

Identifier Source: org_study_id