Personalized Opiate Therapy for Post-Surgical Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study involves opioid-naïve patients, it is likely that you should not be on any opioid medications before participating.
Is hydromorphone safe for use in humans?
Hydromorphone has been studied for safety in various settings, including postoperative pain management and chronic pain. Common side effects are typical of strong painkillers but usually do not require special treatment. No serious heart or breathing problems were observed in the studies reviewed.12345
How is the drug Hydromorphone used in personalized opiate therapy for post-surgical pain different from other treatments?
Hydromorphone in personalized opiate therapy is unique because it considers individual patient responses to opioids, which can vary widely, to tailor the treatment for optimal pain relief. This approach aims to improve patient care by potentially using genetic and biochemical data to predict how well a patient will respond to the drug, unlike standard treatments that often rely on trial and error.678910
What data supports the effectiveness of the drug Hydromorphone for post-surgical pain?
Research shows that hydromorphone is a potent pain reliever, about 3-5 times stronger than morphine and heroin, making it effective for managing post-surgical pain. It is well-accepted by patients and does not cause significant side effects, making it a suitable alternative to other opioids for post-surgical pain relief.1791112
Are You a Good Fit for This Trial?
This trial is for opioid-naive patients who need pain management after surgery. Participants must not have prior dependence on opioids or a history of substance abuse. They should be willing to take hydromorphone if their genetics show they metabolize drugs differently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive personalized opiate therapy based on pharmacogenetics, including hydromorphone for those with specific CYP2D6 metabolic activity
Follow-up
Participants complete a 7-day pain diary post-discharge and receive follow-up phone calls once per month for 90 days
What Are the Treatments Tested in This Trial?
Interventions
- Hydromorphone
Hydromorphone is already approved in United States, Canada, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Tennessee Graduate School of Medicine
Lead Sponsor