Actively Recruiting
OpalGenix- Personalized 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
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone, in adults following lumbar spinal fusion and decompression surgery. Genetic signature and combinatorial pharmacogenetic approaches perform better than single-gene associations. This innovative translational research will for the first time evaluate simultaneously the effects of multiple genes and interactions on oxycodone and methadone's pharmacokinetics and optimal clinical dosing and on its safety and efficacy in the highly vulnerable pediatric population. This research's multigenetic signature findings can be easily extrapolated to adults undergoing surgery or using oxycodone and/or methadone for chronic and cancer pain and in identifying opioid abusers at risk of severe respiratory depression and death. When methadone is given in addition to oxycodone for inpatient pectus excavatum repair and idiopathic scoliosis spinal fusions according to new departmental protocols, methadone pharmacokinetics and pharmacodynamics will also be evaluated.
CONDITIONS
Official 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...
- Over 18 years of age
- American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
- Undergoing lumbar spine surgeries (decompression, multilevel fusion, internal fixation, or combination) for degenerative lumbar spine or lumbar spinal stenosis
- Require opioids for perioperative pain management
You will not qualify if you...
- Younger than 18 years old
- Pregnant women
- American Society of Anesthesiologists (ASA) Physical Status 4 or above
- Non-English speaking
- Outpatient surgery
- Undergoing additional surgical procedures at the same time
- Significant liver or kidney dysfunction
- Significant cardiorespiratory problems
- Use of multiple substances such as cocaine, marijuana, or amphetamines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Alisha Maslanka, BS
CONTACT
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
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