跳至主要内容
临床试验/NCT03210220
NCT03210220已完成不适用

Efficacy of Preoperative Ultrasound Guided Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia in Patients Undergoing Surgery for Breast Cancer.

Gachon University Gil Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Intraoperative Remifentanil Consumption

研究概览

简要总结

The purpose of this study is to determine whether pectoral nerves blocks(PECS) would reduces the opioid consumption during the surgery and postoperative pain after breast cancer surgery.

详细描述

Forty adult female participants scheduled for elective breast cancer surgery under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=20) or general anesthesia alone (control group, n=20).

After arrived in the operating room,all patients undergo operation under total intravenous anesthesia (TIVA) with or without pectoral nerves blocks(PECS) . After anesthesia induction,the participants in the Pecs group receive an ultrasound-guided Pecs block before the start of the operation.

Pecs block technology:After cleaning the infraclavicular and axillary regions , the linear probe is placed below the lateral third of the clavicle. After recognition of the appropriate anatomical structures, then the block is performed . The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .

During operation the remifentanil administration in each group is guided using the surgical pleth index( SPI). the SPI target range was 20 to 50 Anesthetic depth is maintained and continuously adjusted with propofol to achieve Bispectral Index (BIS) between 40 and 60.

primary outcome intraoperative remifentanil consumption secondaty outcome postoperative pain score and rescue analgesic requirement

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

One anesthesiologist (JJC) performed all blocks in the Pecs group enrolled patients. After the intervention, the participants and the investigator responsible for the study outcome assessment were blinded.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists( ASA) I or II Scheduled for breast cancer surgery

排除标准

  • Sensitivity to local anesthetic, Bleeding disorders , Receiving anticoagulant, Body mass index (BMI) > 35/kg/m2 , Spine or chest wall deformity , Pregnancy

结局指标

主要结局

Intraoperative Remifentanil Consumption

时间窗: whole intraoperative period

Intraoperative remifentanil consumption during surgery(whole intraoperative period)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung Ju Choi

assistance professor

Gachon University Gil Medical Center

研究点 (2)

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