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Active, Not Recruiting

NCT Number: NCT06669650

Personalized Post-Operative Pain Management

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Persistent Post Operative Opioid Use Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-surgical Pain Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • <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.

Treatment and study plan

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.

Oxycodone

Drug

oxycodone

Hydromorphone

Drug

hydromorphone

Primary outcomes

  1. Persistent Post-Operative Opioid Use

    Time frame: 90 days

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

Secondary outcomes

  1. Post-Surgical Pain

    Time frame: 7 days

    To determine if PGx guided medication improves post-operative pain scores compared to similar patients who are given the standard current post operative opiate treatment. The scores are being rated using the Face, Legs, Activity, Cry and Consolability scale ranging from a minimum value of 0 to a maximum value of 10.

Other outcomes

  1. Opioid Related Adverse Events

    Time frame: 90 days

    To determine if PGx guided medication reduces total opioid related adverse events compared to standard post operative opiate therapy.

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Registry information

Official study title

Personalized Post-Operative Opiate Prescriptions Based on Pharmacogenetics of CytochromeP450, COMT, and OPRM1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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