Personalized Post-Operative Pain Management

NCT06669650 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: 5226CORNET Award
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Keywords

CYP2D6 SNPs; OPRM1 SNPs; COMT SNPs; Pharmacogenomics

Outcome Measures

Primary Outcomes (1)

• Persistent Post-Operative Opioid Use

  To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication

  90 days

Secondary Outcomes (1)

• Post-Surgical Pain

  7 days

Other Outcomes (1)

• Opioid Related Adverse Events

  90 days

Study Arms (2)

Standard post-operative pain management (control)

ACTIVE COMPARATOR

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.

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

Pharmacogenomics (PGx) guided treatment (hydromorphone)

EXPERIMENTAL

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.

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

Interventions

PGx guided personalized post-operative pain management 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.

Pharmacogenomics (PGx) guided treatment (hydromorphone); Standard post-operative pain management (control)

Oxycodone DRUG

oxycodone

Standard post-operative pain management (control)

Hydromorphone DRUG

hydromorphone

Pharmacogenomics (PGx) guided treatment (hydromorphone)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<18 years of age and \>85 years of age
• Unable to understand study procedures.
• Unwilling to give consent.
• Patients with cognitive impairment that can affect their ability to give consent.
• Previous Surgery \<14 days from time of enrollment.
• Allergies to study intervention or oxycodone.

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

The University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator

Model Details: Standard of Care (oxycodone) versus intervention group (hydromorphone)

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: September 25, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

US (1)