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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorOpalGenix, Inc

About this trial

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

Qualifiers

>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

Disqualifiers

Children (<18 years of age)

Pregnant women

American Society of Anesthesiologists (ASA) Physical Status 4 or above

Non-English speaking

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators