RecruitingNCT05452694

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

Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults


Sponsor

OpalGenix, Inc

Enrollment

235 participants

Start Date

Nov 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized approach to managing pain after lumbar (lower back) spine surgery, using genetic information to guide opioid pain medication choices. Rather than a one-size-fits-all approach, the OpalGenix system tailors the pain management plan to each patient's biology. You may be eligible if: - You are 18 or older - You are scheduled for lumbar spine surgery (decompression, fusion, or fixation) for degenerative spine disease or spinal stenosis - You are expected to need opioid pain medication after surgery - Your physical health status is ASA Class 1, 2, or 3 You may NOT be eligible if: - You are under 18 or pregnant - Your ASA physical status is 4 or higher (very serious health problems) - You do not speak English - You are having outpatient surgery or a separate surgical procedure at the same time - You have significant liver or kidney problems - You have serious heart or lung disease - You use cocaine, marijuana, amphetamines, or other recreational substances Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, United States

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NCT05452694


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