NCT Number: NCT06639438
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Boston, Massachusetts, 02118, United States
Location status: Recruiting
Ala Nozari, MD PhD
CONTACT
Ala Nozari, MD, PhD
PRINCIPAL_INVESTIGATOR
Venetia Zachariou, PhD
PRINCIPAL_INVESTIGATOR
Xuan A He, PhD
CONTACT
The objective for this research are:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Opioid user cohorts:
Control Group Cohorts:
Exclusion criteria
Substance User Cohort:
Control Group Cohort:
Time frame: 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.
Time frame: 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.
Time frame: ~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
Time frame: ~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).
Time frame: Within 1 week of the surgical visit
Anesthesia method will be abstracted from the electronic medical records.
Time frame: Within 1 week of the surgical visit
The total amount of analgesics administered will be abstracted from the electronic medical records.
Time frame: Within 1 week of the surgical visit
Incision site healing status, infection, and any complications will be abstracted from the electronic medical records.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ala Nozari, MD PhD
CONTACT
Xuan He, PhD
CONTACT
Boston Medical Center
Other
Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use
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