Sensory Outcomes in Active Substance Users
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with contraindications for elective surgery
Individuals with no history of opioid use
Individuals with a history of opioid use >20 MME/day or illicit substance use
Patients with contraindications for elective surgery.
Trial population
Subjects with elective spine procedures scheduled involving incision (including laminectomy, discectomy, foraminotomy, scoliosis correction, decompression and fusion) will be divided into four groups: two no opiod use groups and two opioid use groups. The no opioid use groups will consist of two subgroups of participants with no prior pain disorders who have received no long-term opioid prescriptions (n=10), as well as patients with chronic pain disorders who have received no long-term high dose opioid prescriptions (n=10). The opioid use group will consist of two subgroups- participants with OUD (n=10), and participants without OUD, but have been prescribed opioid medication for chronic pain disorders (n=10).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 4 trial groupsGroup A: Group 1- Patients with Opioid Use Disorder (OUD)
Group B: Group 2- Patients who are engaged in long-term opioid therapy (LTOT) for chronic pain
Group C: Group 3- Patients with chronic pain but no (or minimal) opioid use
Group D: Group 4- Patients without chronic pain
Trial outcomes
Primary outcomes
1
Specific gene expressed
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 years2
Type and concentration of inflammatory cells present and selective biomarkers
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
The date of scheduled surgery assessed through the study completion, about two yearsSecondary outcomes
1
Perceived pain using a visual pain scale
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, 36, 48, and 72 hours post-surgery before discharge; ~2 weeks after discharge2
Perceived pain using the McGill pain scale
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
~2 weeks before surgery; 24 hours post-surgery before discharge; ~2 weeks after discharge3
Anesthesia and pain management method
Anesthesia method will be abstracted from the electronic medical records.
Time frame
Within 1 week of the surgical visit4
Opioid burden
The total amount of analgesics administered will be abstracted from the electronic medical records.
Time frame
Within 1 week of the surgical visitSponsors and contacts
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Source ClinicalTrials.gov