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OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults

Recruitingn/aAges 18 Years - 99 YearsAllOpalGenix, Inc
NCT05452694 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 identifyi

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📋 Eligibility rules (as published)
Inclusion Criteria: * \>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 Exclusion Criteria: * 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.)
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What it tests

  • Not listed
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Where

3 sites
UPMC Montefiore Hospital
Pittsburgh, United States
UPMC Presbyterian Hospital
Pittsburgh, United States
UPMC Pain Medicine at Centre Commons
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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