Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy (BAC-UPP 1 Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 主要终点
- Acute Pain after Surgery (using Brief Pain Inventory- Short Form)
研究概览
简要总结
Persistent pain after mastectomy 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 mastectomy and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims:
- We 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.
- We 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.
- We 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.
- We 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 mastectomy. Using a biopsychosocial framework, we 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, we will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
Aim 2: Examine biological and inflammatory mechanisms underlying postoperative pain persistence.
Peripheral blood samples will be collected at multiple time points before and after surgery to quantify circulating markers of inflammation (e.g., IL-6, CRP), neuroendocrine function (e.g., oxytocin, vasopressin), and immune regulation. These biomarkers will be analyzed in relation to clinical pain outcomes to identify biological signatures associated with resilience versus vulnerability to chronic pain. This aim will provide mechanistic insight into how systemic physiological responses to surgery contribute to prolonged nociceptive signaling.
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 breast surgery/mastectomy ; 2) age between 18-65; 3) understanding of verbal and written English.
排除标准
- •1) concurrent medical conditions that could confound the interpretation of the data; 2) HIV positive diagnosis; 3) cardiovascular or pulmonary disease; 4) systemic rheumatoid disease; 5) uncontrolled hypertension (i.e. SBP/DBP of > 150/95); 6) current illness accompanied by fever (body temperature >38 °C); 7) any other chronic pain condition; 8) conditions resulting in altered nerve sensation; 9) hospitalization due to psychiatric illness within the last 6 months; 10) poorly controlled diabetes; 11) history of stroke; 12) history of seizures; 13) circulatory disorders such AS Raynauds' disease 14) history of drug or alcohol abuse.
研究组 & 干预措施
Breast Surgery/Mastectomy Patients
结局指标
主要结局
Acute Pain after Surgery (using Brief Pain Inventory- Short Form)
时间窗: 48 hours after surgery
Pain rating 48 hours after surgery using Brief Pain Questionnaire The BPI-SF is a multidimensional pain scale used to assess self-reported pain severity and its interference with daily functioning. The questionnaire is composed of four items asking about pain severity (worst pain, least pain, average pain, and pain right now) over the past 24 h. Additionally, seven items assess the degree to which pain interferes with functioning in the following domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (no pain or does not interfere) to 10 (worst imaginable pain or completely interferes). Higher scores suggest greater pain severity and pain interference. The BPI-SF is a well validated chronic pain questionnaire that has previously been used in samples with cLBP.
Chronic Pain after Mastectomy (Using Brief Pain Inventory - Short Form)
时间窗: 12 weeks after surgery
Pain measured 3 months following mastectomy The BPI-SF is a multidimensional pain scale used to assess self-reported pain severity and its interference with daily functioning. The questionnaire is composed of four items asking about pain severity (worst pain, least pain, average pain, and pain right now) over the past 24 h. Additionally, seven items assess the degree to which pain interferes with functioning in the following domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (no pain or does not interfere) to 10 (worst imaginable pain or completely interferes). Higher scores suggest greater pain severity and pain interference. The BPI-SF is a well validated chronic pain questionnaire that has previously been used in samples with cLBP.
Chronic Pain after Mastectomy (Using Brief Pain Inventory - Short Form)
时间窗: 12 weeks after surgery
Pain measured 3 months following mastectomy The BPI-SF is a multidimensional pain scale used to assess self-reported pain severity and its interference with daily functioning. The questionnaire is composed of four items asking about pain severity (worst pain, least pain, average pain, and pain right now) over the past 24 h. Additionally, seven items assess the degree to which pain interferes with functioning in the following domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (no pain or does not interfere) to 10 (worst imaginable pain or completely interferes). Higher scores suggest greater pain severity and pain interference. The BPI-SF is a well validated chronic pain questionnaire that has previously been used in samples with cLBP.
Acute Pain after Surgery (using Brief Pain Inventory- Short Form)
时间窗: 48 hours after surgery
Pain rating 48 hours after surgery using Brief Pain Questionnaire The BPI-SF is a multidimensional pain scale used to assess self-reported pain severity and its interference with daily functioning. The questionnaire is composed of four items asking about pain severity (worst pain, least pain, average pain, and pain right now) over the past 24 h. Additionally, seven items assess the degree to which pain interferes with functioning in the following domains: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (no pain or does not interfere) to 10 (worst imaginable pain or completely interferes). Higher scores suggest greater pain severity and pain interference. The BPI-SF is a well validated chronic pain questionnaire that has previously been used in samples with cLBP.
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