OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
Recruiting now
Conditions studied: Lumbar Spine Stenosis, Lumbar Spine Degeneration
In brief
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.
Key facts
- Study ID
- NCT05452694
- Run by
- OpalGenix, Inc
- People needed
- 235
- Starts
- 2022-11-01
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-05-01
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- >18 years of age
- American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
- Undergoing lumbar spine surgeries (lumbar spine decompression, multilevel posterior spine fusion, internal fixation or a combination) for degenerative lumbar spine and lumbar spinal stenosis and requiring opioids for perioperative pain management
You may not qualify if…
- Children (<18 years of age)
- Pregnant women
- American Society of Anesthesiologists (ASA) Physical Status 4 or above
- Non-English speaking
- Outpatient surgery
- Concomitant additional surgical procedures
- Significant liver or kidney dysfunction
- Significant cardiorespiratory compromise
- Patients with polysubstance use (e.g., cocaine, marijuana, amphetamine, etc.)
Where it is running
- UPMC Montefiore Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- UPMC Pain Medicine at Centre Commons — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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