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Understanding Pain in Opioid Users After Spine Surgery

This observational study aims to understand how pain is experienced differently in people who currently use opioids or have a history of opioid use, compared to those who don't, after elective spine surgery. Researchers want to identify unique molecular characteristics related to pain in these groups. They will look at specific genes and inflammatory cells to see how they might contribute to pain. This study is for adults aged 18 and older who are scheduled for elective surgery. For opioid users, this includes individuals with current Opioid Use Disorder (OUD) or those taking at least 20 mg of MME (morphine milligram equivalent) per day for chronic pain. The goal is to better understand and manage post-operative pain, especially since it can be challenging for people with opioid use history.

Study design
This is an observational study planning to enroll 40 participants. It compares individuals with current or previous opioid use to a control group.
What's involved
Participants will complete pain questionnaires at different times around their surgery. Researchers will also collect blood samples to look at immune cells and neuropeptides, and tissue samples from surgical incisions to study skin cells and nerve endings.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of scheduled surgery through the study completion, which is about two years.

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NCT06639438

Sensory Outcomes in Active Substance Users

Recruiting
Not specifiedAges 18+Observational
Boston Medical Center
~40 participants
Updated 2026-02-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Specific gene expressed
Measured over The date of scheduled surgery assessed through the study completion, about two years
+1 more outcome measured

Conditions

Post Operative Pain
Opioid Use, Unspecified

Explore related trials

Chronic PainOpioid Use DisorderPost-Operative Pain

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Ala Nozari, MD PhD · PRINCIPAL_INVESTIGATOR · Boston Medical Center, Anesthesiology

Who to contact

Ala Nozari, MD PhD
[email protected]
617-638-6950
Email the study team

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Eligibility criteria

Inclusion

Individuals with current OUD as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Individuals requiring ≥20 mg of MME/day medication to manage a chronic pain problem.
Patients scheduled to undergo elective surgery
Able to provide informed consent
Individuals who are not taking high dose opioids (≤20 MME/day) nor illicit substances and have no history of opioid use disorder
Individuals with reported chronic pain not yet taking medication for their pain
Patients scheduled to undergo elective surgery
Able to provide informed consent

Exclusion

Patients with contraindications for elective surgery
Individuals with no history of opioid use
Individuals with a history of opioid use \>20 MME/day or illicit substance use
Patients with contraindications for elective surgery.

What this trial measures

  • Specific gene expressedThe date of scheduled surgery assessed through the study completion, about two years

    This outcome will be assessed by the transcriptomic profile of dermal tissue from patient excision site using the Visium system to quantify gene expression changes in the dermis. Dermis tissue, about 5mm (length) x 3mm (width) x 2 mm (depth) in size, will be extracted.

  • Type and concentration of inflammatory cells present and selective biomarkersThe date of scheduled surgery assessed through the study completion, about two years

    The inflammatory profile of whole blood such as the quantity and type of circulating immune cells, e.g. complete blood count (CBC) with differential will be assessed using flow cytometry.A blood sample, about 10mL in volume, will be obtained at the preoperative waiting area immediately after IV placement.