Personalized pain management after lumbar spine surgery
Official title: Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
Run by OpalGenix, Inc · NCT05452694 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 235 (estimated) |
| Sponsor | OpalGenix, Inc Industry-sponsored |
| Locations | 3 sites (Pittsburgh, Pennsylvania and 2 other locations) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | July 18, 2025 |
| Study ends | July 1, 2027 |
| Registry record updated | May 1, 2025 |
| Trial ID | NCT05452694 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies have shown promise in personalized pain management strategies, indicating potential for success.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating LDGraft for lumbar spine surgery
This study is testing a new device called LDGraft to see if it is safe and effective for patients having surgery for lower back problems compared to using human tissue.
-
Evaluating the impact of zolpidem on recovery after lumbar spine fusion surgery
This study is testing if giving a sleep aid called zolpidem to patients having spine surgery can help them recover better and feel less pain.
-
Evaluating text messages versus handouts for lumbar spine surgery recovery
This study is testing whether sending daily text messages or giving out handouts helps adults recover better after lumbar spine surgery by reducing hospital readmissions and improving their pain and anxiety levels.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.