RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults

Quick Facts

Study Start:2022-11-01
Study Completion:2024-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05452694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18 years of age
  2. * American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
  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
  1. * Children (\<18 years of age)
  2. * Pregnant women
  3. * American Society of Anesthesiologists (ASA) Physical Status 4 or above
  4. * Non-English speaking
  5. * Outpatient surgery
  6. * Concomitant additional surgical procedures
  7. * Significant liver or kidney dysfunction
  8. * Significant cardiorespiratory compromise
  9. * Patients with polysubstance use (e.g., cocaine, marijuana, amphetamine, etc.)

Contacts and Locations

Study Contact

Amy Monroe, MPH, MBA
CONTACT
412-623-6382
monroeal@upmc.edu
Alisha Maslanka, BS
CONTACT
412-864-6779
maslankaa@upmc.edu

Principal Investigator

Kathirvel Subramaniam, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: OpalGenix, Inc

  • Kathirvel Subramaniam, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2024-09-30

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2024-09-30

Terms related to this study

Keywords Provided by Researchers

  • Pain Management
  • Lumbar Spine Stenosis
  • Degenerative Lumbar Spine
  • Opioid Use

Additional Relevant MeSH Terms

  • Lumbar Spine Stenosis
  • Lumbar Spine Degeneration