Actively Recruiting
Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
Led by OpalGenix, Inc · Updated on 2025-05-01
235
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how genetic factors influence the effects of two common oral opioids, oxycodone and methadone, in adults after lumbar spinal fusion and decompression surgery. This research aims to better understand how multiple genes together affect opioid processing, dosing, safety, and effectiveness, especially in patients undergoing these painful spine surgeries. The study builds on ongoing efforts to improve personalized pain management and reduce risks of opioid-related problems such as respiratory depression and chronic post-surgical pain. The study involves patients undergoing lumbar spine surgeries who will receive opioids for pain management. It evaluates genetic markers combined with clinical risk factors to predict opioid responses and adverse events. The research uses a personalized approach integrating polygenetic signatures to guide postoperative opioid use. Methadone’s effects will also be assessed when used alongside oxycodone in certain inpatient surgeries. This observational study does not assign treatments but monitors patients’ opioid use and outcomes. Participants will be followed from before surgery through up to 12 months after surgery. Researchers will collect data on opioid-related nausea, sedation, respiratory depression, pain scores, opioid use, length of hospital stay, chronic post-surgical pain, and risks of opioid dependence or disorder. Preoperative assessments include pain tests and brain imaging signals. The study aims to develop tools to help clinicians plan personalized pain management to reduce opioid side effects and improve pain relief after surgery.
CONDITIONS
Brief Title
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
- Scheduled for lumbar spine surgeries such as lumbar spine decompression, multilevel posterior spine fusion, internal fixation, or a combination for degenerative lumbar spine and lumbar spinal stenosis
- Requires opioids for perioperative pain management
You will not qualify if you...
- Under 18 years of age
- Pregnant women
- American Society of Anesthesiologists (ASA) Physical Status 4 or higher
- Non-English speaking
- Outpatient surgery
- Undergoing additional surgical procedures simultaneously
- Significant liver or kidney dysfunction
- Significant cardiorespiratory compromise
- Current polysubstance use such as cocaine, marijuana, or amphetamine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 1 week before surgery
Participants undergo preoperative assessments including genetic testing and pain sensitivity evaluations to personalize pain management plans.
1 to 2 visits (in-person) for preoperative testing
Duration - Hospital stay of up to 1 month post-surgery
Participants undergo lumbar spinal fusion and decompression surgery with inpatient post-surgical pain management and monitoring of opioid-related adverse events.
Daily visits during hospital stay
Duration - Up to 12 months post-surgery
Participants are observed for up to 12 months post-surgery to monitor pain levels, opioid use, and potential adverse events including chronic post-surgical pain and opioid dependence.
Periodic follow-up visits over 12 months, approximately monthly or as scheduled
Trial Site Locations
Total: 3 locations
1
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
3
UPMC Pain Medicine at Centre Commons
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
A
Amy Monroe, MPH, MBA
A
Alisha Maslanka, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here