Clinical trial Recruiting at 3 sites Observational Ages 18 to 99

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 typeObservational
Ages18 Years to 99 Years
SexAll
Enrollment235 (estimated)
SponsorOpalGenix, Inc
Industry-sponsored
Locations3 sites (Pittsburgh, Pennsylvania and 2 other locations)
StatusRecruiting
StartedNovember 1, 2022
Main results expectedJuly 18, 2025
Study endsJuly 1, 2027
Registry record updatedMay 1, 2025
Trial IDNCT05452694 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.

    Recruiting at 4 sites Phase 1/2 Locate Bio Ltd · Fort Wayne, Indiana and 3 other locations · NCT06462729

  • 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.

    Recruiting Phase 4 University of Southern California · Los Angeles, California · NCT05746143

  • 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.

    Recruiting Duke University · Durham, North Carolina · NCT04140344

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.