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NCT06639438 · ClinicalTrials.gov registry record
Sensory Outcomes in Active Substance Users
A clinical trial of Postoperative Pain and Opioid Use, Unspecified, sponsored by Boston Medical Center.
- Recruiting
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT06639438: Recruiting study of Postoperative Pain and Opioid Use, Unspecified, sponsored by Boston Medical Center.
NCT06639438 is a study of Postoperative Pain and Opioid Use, Unspecified that is actively recruiting participants, run by Boston Medical Center. The registered enrollment target is 40 participants, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06639438, a study of Postoperative Pain and Opioid Use, Unspecified, is actively recruiting participants, sponsored by Boston Medical Center.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
Massachusetts
- Boston Medical Center/Boston University Medical Campus - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-02 |
| Est. Completion | 2026-12 |
What NCT06639438 shows while recruiting
NCT06639438 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 0 interventions.
NCT06639438 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06639438 about?
NCT06639438 is a clinical study titled "Sensory Outcomes in Active Substance Users". 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 d...
What is the current status of trial NCT06639438?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2025-02-02. Estimated completion is 2026-12.
What conditions does trial NCT06639438 study?
This clinical trial studies the following conditions: Postoperative Pain, Opioid Use, Unspecified.
Who is sponsoring clinical trial NCT06639438?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06639438 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06639438's enrollment target sits among peer trials
40 109th of 120 higher than 10 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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