NCT05452694 OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
| NCT ID | NCT05452694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OpalGenix, Inc |
| Condition | Lumbar Spine Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 235 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2025-07-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 235 participants in total. It began in 2022-11-01 with a primary completion date of 2025-07-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * \>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 Criteria: * 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.)
Contact & Investigator
Kathirvel Subramaniam, MD, MPH
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05452694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Lumbar Spine Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05452694 currently recruiting?
Yes, NCT05452694 is actively recruiting participants. Contact the research team at monroeal@upmc.edu for enrollment information.
Where is the NCT05452694 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Pittsburgh, United States, Pittsburgh, United States.
Who is sponsoring the NCT05452694 clinical trial?
NCT05452694 is sponsored by OpalGenix, Inc. The principal investigator is Kathirvel Subramaniam, MD, MPH at University of Pittsburgh. The trial plans to enroll 235 participants.