MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 6
- 主要终点
- To compare chronic pain 3 months after breast surgery in each arm
研究概览
简要总结
Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.
详细描述
Before anesthesia, the second or third intercostal space is located. After an aspiration, 0.35 mL/kg of solution (ropivacaine 7.5 mg/mL or saline, maximum 30 mL) are injected into the paravertebral space. After 30 minutes, spread of PVB is evaluated by cold test on skin. Then, general anesthesia is induced.
Evaluation of the frequency of chronic pain at 3, 6 and 12 months by the Brief Pain Inventory (BPI) questionnaire and Neuropathic Pain Diagnostic (DN4) and Anxiety and depression evaluation by the Hospital Anxiety and Depression questionnaire (HAD) will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by:
- •either breast-conserving surgery with axillary lymph node dissection
- •either radical surgery with or without axillary lymph node dissection.
- •18 years ≤ Age ≥ 85 years.
- •ASA class 1, 2 or
- •No analgesic treatment for 2 days (no pre-existing chronic pain)
- •If a biological control has been requested recently or deemed necessary by the Investigator, then it should be satisfactory : Adequate hematologic and hemostasis: neutrophil count (ANC) > 1500/mm3, haemoglobin > 9 g/dl and platelets > 75 000/mm3, prothrombin time > 70%, activated partial thromboplastin time < 1.5 X Upper Limit of Normal (ULN)
- •Life expectancy ≥ 2 years.
- •Signed informed consent form.
- •Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French)
- •Patient affiliated with a health insurance scheme (beneficiary or legal)
- •There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period.
排除标准
- •Ongoing neoplasm or history of malignancy other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial.
- •Bilateral breast carcinoma at the inclusion
- •Male subjects.
- •Metastatic breast carcinoma at diagnosis (M1).
- •Severe heart, liver and respiratory failure (ASA 4)
- •Allergy to local anesthetics and morphine.
- •Use of analgesics during the 48 hours preceding the surgical procedure.
- •History of breast surgery with painful sequelae
- •Major deformation of the spine
- •Puncture site infection
- •History of substance abuse.
- •Pregnant or lactating women, or women of childbearing potential without effective contraception
- •Subjects deprived of their liberty or under guardianship (including temporary guardianship).
- •Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.
研究组 & 干预措施
Placebo
Saline (30 mL maximum)
干预措施: Saline (Drug)
Ropivacaine
Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution)
干预措施: Ropivacaine (Drug)
结局指标
主要结局
To compare chronic pain 3 months after breast surgery in each arm
时间窗: 3 months
Percentage of patients who reported chronic pain 3 months after breast surgery in each arm evaluated by the Brief Pain Inventory, French version. Chronic pain is defined by the item 5 of BPI (upper or equal to 3)
次要结局
- To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)(3 months)
- To determine analgesic consumption(48 postoperative hours)
- To examine incidence of nausea and vomiting(48 postoperative hours)
- To measure acute postoperative pain (Visual Analog Scale (VAS)(48 postoperative hours)
- To measure the extend of dermatomes blocked(one year after surgery)
- To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)(6 and 12 months)
- To compare presence of lymphedema(3, 6 and 12 months)
- To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)(3, 6 and 12 months)
- To evaluate complications of paravertebral block (CTCAE V4.03)(12 months)
- To determine the number of patients reporting pain at 6 months(6 months)