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Personalized Pain Management After Lumbar Spinal Surgery

This observational study is looking at how two common pain medications, oxycodone and methadone, work in adults after lumbar spinal fusion and decompression surgery. Researchers want to understand how your genes might affect how well these medications control pain and if they cause side effects like nausea and vomiting (PONV), too much sleepiness (sedation), or breathing problems (respiratory depression). You could be eligible if you are an adult (18-99 years old) having one of these surgeries for conditions like lumbar spine stenosis or degeneration, and need opioids for pain. The study will track these side effects for up to 12 months after your surgery. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It plans to include 235 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for opioid-related side effects for up to 12 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05452694

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

Recruiting
Not specifiedAges 18–99Observational
OpalGenix, Inc
~235 participants
Updated 2025-05-01 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Opioid-related Post-operative nausea and vomiting (PONV)
Measured over Post-operative up to 12 months
+2 more outcomes measured

Conditions

Lumbar Spine Stenosis
Lumbar Spine Degeneration

Explore related trials

Degenerative Lumbar SpineLumbar Spinal Stenosis

Where it's being run

3 sites across 1 states
Pennsylvania3

Study leadership

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

Who to contact

Amy Monroe, MPH, MBA
[email protected]
412-623-6382
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\>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

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.)

What this trial measures

  • Opioid-related Post-operative nausea and vomiting (PONV)Post-operative up to 12 months

    PONV is measured with a binary yes/no response

  • Opioid-related sedationPost-operative up to 12 months

    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.

  • Opioid-related respiratory depression (RD)Post-operative up to 12 months

    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.