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

Inclusion Criteria3

  • \>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 Criteria9

  • 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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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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