A Double-blind Randomized Trial of Interpectoral Nerve Block (Pecs 1 and 2) With Ropivacaine Versus Placebo Before Breast Cancer Surgery: Effects on Acute Postoperative Pain. (MIRs 04)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- To compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery
研究概览
简要总结
Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.
详细描述
Before surgery, the 3rd interpectoral space will be identified. After aspiration, half of the solution of Ropivacaine 5 mg/ml not exceeding 3 mg/kg of maximal dose and 30 ml of maximal volume or saline (not exceeding 30 ml of maximal volume) will be injected into the interpectoral space underneath the pectoralis major muscle for the Pecs 1 block. The other half of the solution will be injected above the serratus anterior muscle at the third rib.
Evaluation of the percentage of patients treated with step 2 or 3 analgesics during the three postoperative hours.
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)
盲法说明
Double
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 breast-conserving surgery (tumorectomy) with sentinel node technique on one day surgery.
- •Age between 18 and 85 years.
- •ASA class 1, 2 or 3
- •Signed informed consent form.
排除标准
- •Ongoing neoplasm or history of neoplasm 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.
- •Axillary dissection planned during surgery planning
- •All bilateral surgery the day of Pecs administration
- •Metastatic breast carcinoma at diagnosis (M1).
- •Allergy to local anesthetics and morphine.
- •Use of analgesics during the 12 hours preceding the surgical procedure.
- •History of ipsilateral surgery during the previous 6 months.
- •History of substance abuse.
- •Pregnant woman or breastfeeding.
- •Subjects deprived of their liberty or under guardianship (including temporary guardianship).
- •Subjects no covered by social security scheme
- •Experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.
- •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
研究组 & 干预措施
Placebo
Saline (30 mL maximum)
干预措施: Saline (Drug)
Ropivacaïne
Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume)
干预措施: Ropivacaine (Drug)
结局指标
主要结局
To compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery
时间窗: 3 hours
Percentage of patients treated with step 2 or 3 analgesics during the first three postoperative hours after tumorectomy plus sentinel lymph node dissection, between the group with Ropivacaïne and the group with placebo
次要结局
- Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours(48 hours)
- Evaluation of acute pain until 48 postoperative hours(48 hours)
- Evaluation of patient's satisfaction on pain management(48 hours)
- Evaluation of Remifentanil consumption during anesthesia(3 hours)
- Evaluation of analgesic consumption during the first 48 postoperative hours(48 hours)
- Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours(48 hours)
- Evaluation of complications of Pecs during 48 postoperative hours(48 hours)
- Evaluation of the incidence of serious adverse events during 30 days(30 days)