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

NCT05452694 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 235

Last updated 2025-05-01

No results posted yet for this study

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.

Conditions

  • Lumbar Spine Stenosis
  • Lumbar Spine Degeneration

Sponsors & Collaborators

  • OpalGenix, Inc

    lead INDUSTRY

Principal Investigators

  • Kathirvel Subramaniam, MD, MPH · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-07-18
Completion
2027-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452694 on ClinicalTrials.gov