Recruiting

Observational Study

Sponsor:

Boston Medical Center

Code:

NCT06639438

Conditions

Post Operative Pain

Opioid Use, Unspecified

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The incidence and severity of postoperative pain after spine surgery are notably high, often requiring intensive management and potentially affecting the patient's recovery, satisfaction, and long-term outcomes. Post-operative pain is particularly difficult to manage in patients with substance use disorder likely due to a combination of withdrawal symptoms and molecular changes in the pain matrix. Opiates are the leading cause of overdose related fatalities, and carry a significant burden of substance related morbidity and mortality. As over 80% of patients undergoing low-risk surgery receive opioid prescriptions, the investigators aim to identify unique molecular characteristics of pain within current and previous opioid users, which have been understudied in this context. This study also seeks to understand the molecular mechanisms underlying worsened postoperative pain in patients with opioid use disorder (OUD).

Flow cytometry analysis of human serum will be done, which will assess circulating immune cells that can contribute to exacerbated surgery site inflammation. Spatial profiling of gene expression will be done in the dermis using Visium slide sequencing, focusing on the interplay between nerve endings, resident immune cells, and supporting dermal cells, all of which collectively contribute to the sensation pain. Both the visual pain rating scale and McGill Pain Questionnaire will be used to comprehensively quantify pain outcomes during the participant's postoperative recovery stay after surgery in an effort to better understand postoperative pain management with biomarkers of worsened postoperative pain.

Conditions

Post Operative Pain

Opioid Use, Unspecified

Study ID

NCT06639438

Start date

Feb 2, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1- Patients with Opioid Use Disorder (OUD)

Participants in this group will be diagnosed with OUD, defined by cognitive, behavioral, and physiological symptoms indicating using opioids despite significant opioid-related problems.

Group 2- Patients who are engaged in long-term opioid therapy (LTOT) for chronic pain

Participants in this group will be engaged in long-term opioid therapy (LTOT) for chronic pain management under medical supervision, without exhibiting the problematic behaviors or experiencing the significant impairment or distress outlined in the OUD criteria.

Group 3- Patients with chronic pain but no (or minimal) opioid use

Participants in this group will have chronic pain but no (or minimal) opioid use where chronic pain is defined as pain that lasts more than three months or beyond the expected period of healing but opioid use is < 20MME with <3 weeks of duration.

Group 4- Patients without chronic pain

Participants in this group will not suffer from chronic pain but choose to undergo spine surgery due to structural abnormalities or conditions that could potentially lead to pain, neurological issues, or other significant health problems

Primary outcome measure

  • Specific gene expressed [ Time Frame: The date of scheduled surgery assessed through the study completion, about two years ]
  • Type and concentration of inflammatory cells present and selective biomarkers [ Time Frame: The date of scheduled surgery assessed through the study completion, about two years ]

Central Contacts and Locations

Central contacts

Locations

Boston Medical Center/Boston University Medical Campus

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Principal Investigator:

Venetia Zachariou, PhD

More Information

Sponsor

Boston Medical Center

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Opioid use disorder (OUD)
  • Gene expression
  • Visium slide sequencing
  • Inflammatory profile
  • Sensation pain
  • Flow cytometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-02-10.