Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT05452694

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

Led by OpalGenix, Inc · Updated on 2025-05-01

235

Participants Needed

3

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
  • Undergoing lumbar spine surgeries (decompression, multilevel fusion, internal fixation, or combination) for degenerative lumbar spine or lumbar spinal stenosis
  • Require opioids for perioperative pain management
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Pregnant women
  • American Society of Anesthesiologists (ASA) Physical Status 4 or above
  • Non-English speaking
  • Outpatient surgery
  • Undergoing additional surgical procedures at the same time
  • Significant liver or kidney dysfunction
  • Significant cardiorespiratory problems
  • Use of multiple substances such as cocaine, marijuana, or amphetamines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

2

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

3

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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Research Team

A

Amy Monroe, MPH, MBA

CONTACT

A

Alisha Maslanka, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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