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

NCT05452694 | Recruiting

• 1 other identifier: STUDY22010019
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 3

Brief Summary

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

Lumbar Spine Stenosis; Lumbar Spine Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Opioid-related Post-operative nausea and vomiting (PONV)

  PONV is measured with a binary yes/no response

  Post-operative up to 12 months

• Opioid-related sedation

  Sedation will be measured using the Riker Sedation Scale. The minimum score of 1 categorizes the patient as being unarousable, while the maximum score of 7 categorizes the patient as being dangerous agitation.

  Post-operative up to 12 months

• Opioid-related respiratory depression (RD)

  Respiratory depression is defined as abnormally slow respiratory rate which is below 12 breaths per minute. This will be measured with a binary yes/no response pulled from the electronic medical records.

  Post-operative up to 12 months

Secondary Outcomes (13)

• Opioid use

  Pre-operative to post-operative up to 12-months

• Post-operative Pain Scores

  Pre-operative to post-operative up to 12-months

• Length of Hospital Stay

  Post-operative day 1 up to 1-month

• Chronic Post-surgical Pain (CPSP)

  Post-operative up to 12 months

• Length of Prescribed Opioid Usage

  Post-operative up to 12-months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be adults undergoing lumbar spine surgeries that fit the inclusion criteria. Children will not be included as they are not seen at the specific site institution. Given the nature of the surgical procedure, pregnant women and women that may be pregnant will also not be included in this study population.

You may qualify if:

• \>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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• OpalGenix, Inc: lead

Study Sites (3)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

One blood collection will take place at the baseline visit consisting of 1 EDTA tube which will collect approximately 2-3mL. This blood collection will be used for genotyping CYP2D6.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathirvel Subramaniam, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

412-623-6382; monroeal@upmc.edu

Alisha Maslanka, BS

CONTACT

412-864-6779; maslankaa@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: November 1, 2022
• Primary Completion: July 18, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)