Sensory Outcomes in Active Substance Users

Recruiting

• Conditions: Post Operative Pain; Opioid Use, Unspecified

• Registration Number: NCT06639438
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

The objective for this research are:

1. Assess differences in pain reception in patients with existing or previous opioid use disorder versus controls after elective spine surgery via pain questionnaires at multiple time points during the perioperative care.

2. Assess circulating immune signatures and neuropeptides associated with pain signaling before and after surgery in patients with and without OUD using flow cytometry and ELISA of patient serum.

3. Assess molecular signatures of dermal cells and nerve endings patients with and without OUD using spatial transcriptomics on epidermis- and dermis-containing tissue samples from surgical incision.

Study Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Status Verified: 2025-02
• Study Start: 2025-02-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specific gene expressed	The 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 biomarkers	The 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.

Secondary Outcome Measures

Name	Time	Method
Perceived pain using a visual pain scale	~2 weeks before surgery; 24, 36, 48, and 72 hours post-surgery before discharge; ~2 weeks after discharge	standard Wong-Baker FACES® Pain Rating Scale of 0-10, 0 being no pain, 10 being worst pain
Perceived pain using the McGill pain scale	~2 weeks before surgery; 24 hours post-surgery before discharge; ~2 weeks after discharge	The McGill Pain Questionnaire (MPQ) is composed of 78 words. Respondents choose those that best describe their experience of pain.The McGill pain scale descriptors fall into four groups: sensory, affective, evaluative, and miscellaneous. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
Anesthesia and pain management method	Within 1 week of the surgical visit	Anesthesia method will be abstracted from the electronic medical records.
Opioid burden	Within 1 week of the surgical visit	The total amount of analgesics administered will be abstracted from the electronic medical records.
Post-operative recovery and complications	Within 1 week of the surgical visit	Incision site healing status, infection, and any complications will be abstracted from the electronic medical records.
Perceived pain during postsurgical recovery using the remote pain survey.	1, 2, 3, 4 week post-discharge	Investigator-developed pain survey that describes the pain level, location, and how it affects quality of life. The survey contains a pain scale from 0 to 10 with 0 being no pain and 10 being worst pain. The survey also contains non-numerical measures describing the location and impact of the pain.

Trial Locations

Locations (1)

Boston Medical Center/Boston University Medical Campus; 🇺🇸 Boston, Massachusetts, United States