Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use
概览
- 阶段
- 不适用
- 干预措施
- Group 1- Patients with Opioid Use Disorder (OUD)
- 疾病 / 适应症
- Post Operative Pain
- 发起方
- Boston Medical Center
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Specific gene expressed
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Group 1- Patients with Opioid Use Disorder (OUD)
Participants in this group will be diagnosed with OUD, defined by cognitive, behavioral, and physiological symptoms indicating using opioids despite significant opioid-related problems.
Group 2- Patients who are engaged in long-term opioid therapy (LTOT) for chronic pain
Participants in this group will be engaged in long-term opioid therapy (LTOT) for chronic pain management under medical supervision, without exhibiting the problematic behaviors or experiencing the significant impairment or distress outlined in the OUD criteria.
Group 3- Patients with chronic pain but no (or minimal) opioid use
Participants in this group will have chronic pain but no (or minimal) opioid use where chronic pain is defined as pain that lasts more than three months or beyond the expected period of healing but opioid use is \< 20MME with \<3 weeks of duration.
Group 4- Patients without chronic pain
Participants in this group will not suffer from chronic pain but choose to undergo spine surgery due to structural abnormalities or conditions that could potentially lead to pain, neurological issues, or other significant health problems
结局指标
主要结局
Specific gene expressed
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Perceived pain using the McGill pain scale(~2 weeks before surgery; 24 hours post-surgery before discharge; ~2 weeks after discharge)
- Anesthesia and pain management method(Within 1 week of the surgical visit)
- Opioid burden(Within 1 week of the surgical visit)
- Post-operative recovery and complications(Within 1 week of the surgical visit)
- Perceived pain during postsurgical recovery using the remote pain survey.(1, 2, 3, 4 week post-discharge)