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NCT05452694
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
trial in Lumbar Spine Stenosis in 235 participants. Currently enrolling.
18 July 2025
Quick facts
| Lead sponsor | OpalGenix, Inc |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 235 |
| Start date | 1 November 2022 |
| Primary completion | 18 July 2025 |
| Estimated completion | 1 July 2027 |
| Sites | 3 locations across United States |
Conditions studied
- Lumbar Spine Stenosis — all drugs for Lumbar Spine Stenosis →
- Lumbar Spine Degeneration — all drugs for Lumbar Spine Degeneration →
Sponsor
OpalGenix, Inc — full company profile →
Who can join
Adults 18 to 99, any sex, with Lumbar Spine Stenosis or Lumbar Spine Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Role of Pharmacogenetic Biomarkers in Pain.
Martin da Silva I, Plaza-Díaz A, Ruiz-Ramos J, Juanes-Borrego A, et al · · 2025 · cited 1× · PMID 40868188 · DOI 10.3390/biomedicines13081935
Verify or expand the search:
- PubMed search for NCT05452694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lumbar Spine Stenosis
Currently open trials in the same condition.
- NCT07349719 — Dynamic Compliance-Guided Ventilation in Lumbar Surgery · NA · recruiting
Other OpalGenix, Inc trials
Trials by the same sponsor.
- NCT05525923 — Personalized Postoperative Pain Management Following Thoracic Surgery in Adults · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05452694 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by OpalGenix, Inc
- Last refreshed: 1 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05452694.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing