Personalized pain management after lumbar spine surgery
Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
This study is testing how genetic factors affect pain management after back surgery to see if it can help adults use opioids more safely and effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 235 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | OpalGenix, Inc Industry-sponsored |
| Locations | 3 sites (Pittsburgh, Pennsylvania and 2 other locations) |
| Trial ID | NCT05452694 on ClinicalTrials.gov |
What this trial studies
This research focuses on improving postoperative pain management for adults undergoing lumbar spinal fusion and decompression surgery by evaluating the effects of genetic factors on the efficacy and safety of commonly used opioids, oxycodone and methadone. It aims to identify how multiple genes interact to influence pain perception and opioid responses, which could lead to more personalized and effective pain management strategies. The study addresses the high incidence of uncontrolled pain and opioid-related adverse effects in this patient population, aiming to reduce the risks associated with opioid use. By understanding these genetic influences, the research seeks to optimize opioid dosing and minimize complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are undergoing lumbar spine surgeries and require opioids for pain management.
Not a fit: Patients who may not benefit from this study include those under 18 years old, pregnant women, or individuals with significant comorbidities or substance use issues.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer pain management strategies for patients undergoing lumbar spine surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in personalized pain management strategies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Pittsburgh, Pennsylvania and 2 other locations
- UPMC Montefiore Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC Pain Medicine at Centre Commons — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kathirvel Subramaniam, MD, MPH — University of Pittsburgh
- Study coordinator: Amy Monroe, MPH, MBA
- Email: monroeal@upmc.edu
- Phone: 412-623-6382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.