Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
OpalGenix, Inc
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.
Description
Multilevel lumbar spinal fusion and decompression surgeries (LSS) are common and extremely painful inpatient procedures associated with severe post-surgical pain, high incidence of CPSP, persistent and excessive opioid use, unsafe opioid prescribing and development of opioid use disorder (OUD), along with costly immediate postoperative opioid adverse events (AEs) and long hospital stays. Opioids are still widely used to manage acute surgical pain and remain a core component of multi-modal analgesic and enhanced recovery after surgery protocols (ERAS) for painful surgeries. About half of LSS pa…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 * Sig…
Locations (3)
- UPMC Montefiore HospitalPittsburgh, Pennsylvania
- UPMC Presbyterian HospitalPittsburgh, Pennsylvania
- UPMC Pain Medicine at Centre CommonsPittsburgh, Pennsylvania