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NCT06639438 · ClinicalTrials.gov registry record

Sensory Outcomes in Active Substance Users

A clinical trial of Post Operative Pain and Opioid Use, Unspecified, sponsored by Boston Medical Center.

Recruiting
Registry status
40
Enrollment target
1
Study location

NCT06639438 is a study of Post Operative Pain and Opioid Use, Unspecified that is actively recruiting participants, run by Boston Medical Center. The registered enrollment target is 40 participants, below the 236-participant average among 56 other Post Operative Pain trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06639438, a study of Post Operative 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.

Study Locations (1)

Massachusetts

  • Boston Medical Center/Boston University Medical Campus - Boston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-02-02
Est. Completion 2026-12

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT06639438

The ClinicalTrials.gov registry entry for NCT06639438 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 236-participant average among 56 other Post Operative Pain trials with a reported enrollment target (83% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Post Operative Pain appearing as the primary indexed condition, and to 0 interventions.

NCT06639438 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Post Operative 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.

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