Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain: A Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Somatization: Measured using the SCL-90-R-Somatization
研究概览
简要总结
The investigators will approach elective cardiac and thoracic surgery patients in the preoperative consultation clinic. Consenting individuals will be administered, before surgery validated pain, psychological and sleep questionnaires. These questionnaires will be repeated at 3, 6 and 12 months postoperatively (PO) to follow up the progression of early PO pain and the transition to chronicity. Participants will define clinically relevant pain by calculating a chronic pain index (CPI). In addition, the investigators will follow the development of acute postsurgical and chronic pain from before surgery up to a year after, extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain.
详细描述
Most patients who undergo surgery heal within weeks to months and return to their baseline functional status or to an improved level of functioning. However, some patients have pain after surgery which continues. The purpose of this study is to see if there is a relationship between patient's genetic makeup (diseases that are passed on in families) and pain experience following cardiac and thoracic surgeries. This study will look for links between psychological factors, environmental factors and genetic factors in an attempt to uncover the risk for developing chronic post-surgical pain.
This study hopes to determine differences between traditional pain surveys and a basic science approach called "Phenomics" to measure chronic pain response after cardiac and thoracic surgery. Phenomics or Phenomes is the study of physical characteristics, outside influences and biochemical changes (traits or chemical characteristics) and their response to either the environment or genetic changes. Validated pain questionnaires will be administered before surgery, and will repeated at 3, 6, and 12 months postoperatively to follow up the progression of early postoperative pain and the transition to chronicity. In general, the psychological and pain questionnaires are designed to measure the following: anxiety, thoughts, feelings and reactions toward pain and stressful experiences.
In addition, the study will follow the development of acute postoperative and chronic pain from before surgery up to a year after. The investigators will extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain. The blood sample will be drawn at the time of the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Non- Emergency Cardiac Surgery with Midline Sternotomy OR Thoracic Surgery via VATS or Lateral Thoracotomy
- •Written informed consent to participate in the study
排除标准
- •Patient unable to understand the study protocol
- •History of a psychotic psychiatric disorder
- •Unable to speak English
结局指标
主要结局
Somatization: Measured using the SCL-90-R-Somatization
时间窗: 1 year from the day of surgery
The SCL-90-R is a widely-used self-report symptom inventory measuring psychological symptoms of psychiatric and medical patients. Participants rate each item on a five-point scale of distress, ranging from 0 (no distress) to 4 (extreme distress).
Post-Surgical Pain Intensity
时间窗: 1 year from the day of surgery
Measured using the numeric rating scale (0=no pain; 10=worst pain imaginable)
Pain Disability: Measured using the Pain Disability Index (PDI)
时间窗: 1 year from the day of surgery
The PDI assesses the extent to which persistent pain interferes with an individual's ability to engage in seven different areas of everyday activity including: (1) family/home responsibilities, (2) recreation, (3) social activity, (4) occupation, (5) sexual behavior, (6) self-care, and (7) life-support activity.
Sleep Problems: Measured using the Sleep Problems Questionnaire
时间窗: 1 year from the day of surgery
This is a general questionnaire that asks its questions providing responses in units of days.
Pain Catastrophizing: Measured using the Pain Catastrophizing Scale (PCS)
时间窗: 1 year from the day of surgery
The PCS consists of 13 items describing thoughts and feelings that individuals may experience when they are in pain. Each item is rated on a 5-point scale ranging from not at all (0) to all the time (4).
Posttraumatic Stress Disorder: Measured using the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C)
时间窗: 1 year from the day of surgery
The Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C) is a 17-item self-report measure based on the current DSM-IV symptoms for PTSD. Respondents are asked to indicate how much they have been bothered by each symptom 5-point scale ranging from not at all (1) to extremely (5).
Anxiety and Depression: Measured using The Hospital Anxiety and Depression Scale (HADS)
时间窗: 1 year from the day of surgery
The HADS is the most widely used scale for measuring symptoms of anxiety and depression among medical inpatients, outpatients and the general population and consists of 7 anxiety and 7 depression-related items.
Pain: Measured using the McGill Pain Questionnaire- Short Form-2 (SF-MPQ-2)
时间窗: 1 year from the day of surgery
The SF-MPQ-2 is a 22-item, expanded and revised version of the SF-MPQ designed to measure the qualities of neuropathic and non-neuropathic pain. Exploratory and confirmatory factor analyses revealed the presence of the following four factors or subscales: (1) continuous pain, (2) intermittent pain, (3) neuropathic pain, and (4) affective pain descriptor.
Anxiety: Measured using the Anxiety Sensitivity Index-3 (ASI-3)
时间窗: 1 year from the day of surgery
The ASI-3 is a revised version of the widely used, 16-item scale ASI that measures concerns that anxiety and anxiety-related symptoms will lead to harmful negative consequences. Each item is rated on a 5-point scale ranging from very little (0) to very much (4).
Chronic Pain Acceptance: Measured using the Chronic Pain Acceptance Questionnaire (CPAQ)
时间窗: 1 year from the day of surgery
The CPAQ is a 20-item questionnaire that measures how participants react and adapt to living with chronic pain. Participants respond to "how true" each item is by selecting a number from 0 ("never true") to 6 ("always true").
Pain Self Efficacy: Measured using the Pain Self-Efficacy Questionnaire (PSEQ)
时间窗: 1 year from the day of surgery
The PSEQ is a 10-item Likert-type questionnaire, designed specifically for chronic pain, where patients are asked to rate their confidence to complete certain activities despite pain.
Sensitivity to Pain Traumatization: Measured using the Sensitivity to Pain Traumatization Scale (SPTS)
时间窗: 1 year from the day of surgery
The SPTS is a 12-item questionnaire that was designed to measure the anxiety-related cognitive, emotional and behavioural reactions to pain that resemble symptoms of a traumatic stress reaction. Each item is rated on a 5-item Likert scale (from 1 (not at all true) to 5 (entirely true)).
Pain: Measured using the Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (SLANSS)
时间窗: 1 year from the day of surgery
The S-LANSS is a validated 7-item questionnaire designed to distinguish whether pain is predominately neuropathic or nociceptive in origin.
Pain Anxiety: Measured using the Pain Anxiety Symptoms Scale-20 (PASS-20)
时间窗: 1 year from the day of surgery
The PASS-20 is a shortened 20-item version of the original Pain Anxiety Symptoms Scale designed to measure fear and anxiety responses specific to pain, including avoidance. The PASS-20 has four 5-item subscales, including (1) cognitive anxiety, (2) escape and avoidance, (3) fearful thinking, and (4) physiological anxiety.
Mindful Attention Awareness: Measured using the Mindful Attention Awareness Scale (MAAS)
时间窗: 1 year from the day of surgery
The MAAS is a 15-item scale designed to measure a central feature of dispositional mindfulness characterized by "open or receptive awareness of and attention to" the present. Participants respond to how frequently/infrequently they experience each item by selecting one of six response options on a Likert rating scale ranging from 1 ("Almost always") to 6 ("Almost never").
Sleep Quality: Measured using the Pittsburg Sleep Quality Index (PQSI)
时间窗: 1 year from the day of surgery
The PSQI questionnaire is much more specific, identifying specific responses and reasons why patients may be having trouble sleeping such as: (1) cannot get to sleep within 30 minutes and (2) wake up in the middle of the night or early morning.
次要结局
- Pain: Measured using the Vasoconstrictor Inspiratory Gasp(1 year from the day of surgery)
- Physical Activity for Thoracic Patients: Measured using Actiwatch--64(Up to 11 days from surgery)
- Mechanical Pain Pressure: Measured using the Mechanical Pressure Pain Threshold (PPT)(1 year from the day of surgery)
- Sleep Quality for Thoracic Patients: Measured using the Sleep Quality Assessment(Up to 11 days from surgery)
- Cold Pressor Pain: Measured using the Cold Pressor Pain Test(1 year from the day of surgery)
- Thermal Pain and Sensory: Measured using the Thermal Pain and Sensory Thresholds(1 year from the day of surgery)
- Pain Illusion: Measured using the Thermal Grill Illusion Test(1 year from the day of surgery)