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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
OpalGenix, Inc
Study ID
NCT05452694
Status
Recruiting
Apply to this trial

Conditions

  • Lumbar Spine Degeneration
  • Lumbar Spine Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Nov 1, 2022
Status verified
Apr 2025
Primary completion
Jul 18, 2025
Completion
Jul 1, 2027

Study Design

Enrollment
235 participants (estimated)

Primary Outcome Measure

Opioid-related Post-operative nausea and vomiting (PONV) [ Time Frame: Post-operative up to 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UPMC Montefiore HospitalPittsburghPennsylvania15213
Kathirvel Subramaniam, MD
[email protected]
Amy Monroe, MPH, MBA
[email protected]
412-623-6382
UPMC Pain Medicine at Centre CommonsPittsburghPennsylvania15232
Kathirvel Subramaniam, MD
[email protected]
Amy Monroe, MPH, MBA
[email protected]
412-623-6382
UPMC Presbyterian HospitalPittsburghPennsylvania15213
Kathirvel Subramaniam, MD, MPH
[email protected]
Amy Monroe, MPH, MBA
[email protected]
412-623-6382

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By research site
UPMC Montefiore Hospital· Pittsburgh, PAUPMC Pain Medicine at Centre Commons· Pittsburgh, PAUPMC Presbyterian Hospital· Pittsburgh, PA

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