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NCT05452694 · ClinicalTrials.gov registry record
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
A clinical trial of Lumbar Spine Degeneration and Lumbar Spine Stenosis, sponsored by OpalGenix.
- Recruiting
- Registry status
- 235
- Enrollment target
- 3
- Study locations
NCT05452694 is a study of Lumbar Spine Degeneration and Lumbar Spine Stenosis that is actively recruiting participants, run by OpalGenix. The registered enrollment target is 235 participants, below the 610-participant average among 7 other Lumbar Spine Degeneration trials with a reported enrollment target (61% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT05452694, a study of Lumbar Spine Degeneration and Lumbar Spine Stenosis, is actively recruiting participants, sponsored by OpalGenix.
- RECRUITING
- Registry status
- 235 participants
- Enrollment target
- 3
- Study locations
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 Studied
Study Locations (3)
Pennsylvania
- UPMC Montefiore Hospital - Pittsburgh
- UPMC Presbyterian Hospital - Pittsburgh
- UPMC Pain Medicine at Centre Commons - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2027-07-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05452694
The ClinicalTrials.gov registry entry for NCT05452694 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 610-participant average among 7 other Lumbar Spine Degeneration trials with a reported enrollment target (61% lower). The listed sponsor is OpalGenix, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lumbar Spine Degeneration appearing as the primary indexed condition, and to 0 interventions.
NCT05452694 reports 3 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05452694 about?
NCT05452694 is a clinical study titled "OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults". 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 de...
What is the current status of trial NCT05452694?
This trial is currently recruiting. The enrollment target is 235 participants. The study started on 2022-11-01. Estimated completion is 2027-07-01.
What conditions does trial NCT05452694 study?
This clinical trial studies the following conditions: Lumbar Spine Degeneration, Lumbar Spine Stenosis.
Who is sponsoring clinical trial NCT05452694?
This trial is sponsored by OpalGenix, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05452694 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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