Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery (BAC-UPP 2 Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- Acute Pain after Surgery
研究概览
简要总结
Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal surgery and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims:
- The investigators will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery.
- The investigators will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases.
- The investigators will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery.
- The investigators will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.
详细描述
The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following colorectal surgery. Using a biopsychosocial framework, the investigators aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following colorectal surgery. Using a biopsychosocial framework, the investigators aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, the investigators will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants scheduled for colorectal cancer surgery
- •Age between 18-65; 3)
- •Understanding verbal and written English
排除标准
- •Concurrent medical conditions that could confound the interpretation of the data
- •Human immunodeficiency virus positive diagnosis
- •Cardiovascular or pulmonary disease
- •Systemic rheumatoid disease
- •Uncontrolled hypertension (i.e. SBP/DBP of > 150/95
- •Current illness accompanied by fever (body temperature >38 °C)
- •Any other chronic pain conditions
- •Conditions resulting in altered nerve sensation
- •Hospitalization due to psychiatric illness within the last 6 months
- •Poorly controlled diabetes
- •History of stroke
- •History of seizures
- •Circulatory disorders such AS Raynauds' disease
- •History of drug or alcohol abuse.
研究组 & 干预措施
Colorectal Surgery Patients
Patients undergoing colorectal surgery
结局指标
主要结局
Acute Pain after Surgery
时间窗: 48 hours after surgery
Pain rating 48 hours after surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.
Chronic Pain after colorectal surgery
时间窗: 12 weeks after surgery
Pain Measured 3 months following colorectal surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.
次要结局
未报告次要终点
研究者
Demario Overstreet
Assistant Professor of Surgery
University of Alabama at Birmingham