Understanding pain in patients with opioid use disorder after spine surgery
Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use
This study looks at how pain after spine surgery is different for people with opioid use disorder compared to those without, to help find better ways to manage their pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06639438 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the differences in postoperative pain experiences between patients with opioid use disorder (OUD) and those without after elective spine surgery. It will utilize pain questionnaires, flow cytometry, and spatial transcriptomics to assess pain reception, immune signatures, and molecular characteristics associated with pain signaling. By examining these factors, the study seeks to uncover the underlying mechanisms that contribute to heightened postoperative pain in individuals with a history of opioid use. The findings could provide insights into tailored pain management strategies for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include individuals with current opioid use disorder requiring high doses of opioids for chronic pain and those without a history of opioid use undergoing elective spine surgery.
Not a fit: Patients with contraindications for elective surgery or those with no history of opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients with opioid use disorder, enhancing their recovery and overall satisfaction after surgery.
How similar studies have performed: While studies have explored pain management in opioid users, this specific approach focusing on molecular characteristics in the postoperative setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Opioid user cohorts: * 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 Control Group Cohorts: * 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 Criteria: Substance User Cohort: * Patients with contraindications for elective surgery * Individuals with no history of opioid use Control Group Cohort: * Individuals with a history of opioid use \>20 MME/day or illicit substance use * Patients with contraindications for elective surgery.
Where this trial is running
Boston, Massachusetts
- Boston Medical Center/Boston University Medical Campus — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ala Nozari, MD PhD — Boston Medical Center, Anesthesiology
- Study coordinator: Ala Nozari, MD PhD
- Email: ala.nozari@bmc.org
- Phone: 617-638-6950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.