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临床试验/NCT02103946
NCT02103946撤回不适用

Serratus Anterior Muscle Plane Block Versus Paravertebral Block for Breast Cancer Resections.

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
pain relief

研究概览

简要总结

ًًًُُُُThe investigators are testing the efficacy of a new novel technique; serratus anterior plane block, for preventing postoperative pain after breast surgery for cancer. This block will be compared with the well-established paravertebral block.

详细描述

Paravertebral block (PVB) can be considered as a well-established option to provide anesthesia and postoperative analgesia during breast surgery. For patients receiving a PVB alone or in combination with general anesthesia significant lower resting, evoked and worst pain scores compared with other analgesic treatment strategies indicating that a PVB provides improved postoperative pain control in patients undergoing breast surgery. Furthermore, there might be a reduced need for postoperative opioid requirements and consecutively a decrease in opioid-induced adverse effects in patients receiving a PVB. Anyways there are always fear of pleural injury and pneumothorax in addition to epidural and intrathecal spread of the block. A novel newly introduced field block has been described recently to block the hemithorax under ultrasound guidance that is the Serratus Anterior Muscle Plane SAM block. Still this technique to the investigators knowledge is not tried in randomized clinical studies. The aim of this study is to find out that this new technique is comparable to PVB in patients undergoing breast surgeries with or without axillary node dissection.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •unilateral mastectomy with or without axillary lymph node dissection.
  • •American Society of Anesthesia (ASA) I&II

排除标准

  • •morbid obesity (body mass index > 40 kg/m2);
  • •renal insufficiency (creatinine > 1.5 mg/dL),
  • •current chronic analgesic therapy (daily use > 4 weeks),
  • •a history of opioid dependence, pregnancy,
  • •inability to communicate with the investigators or hospital staff,
  • •American Society of Anesthesia (ASA) III-IV

研究组 & 干预措施

Serratus anterior muscle plane block

Active Comparator

Serratus anterior muscle plane block with general anesthesia MARCAINE® 0.25%w/v solution for injection. DIPRIVAN® (propofol), 2 to 2.5 mg/kg NIMBEX® (cisatracurium besylate) Injection, 0.15-0.2 mg\Kg Fentanyl, 1-2 mic\Kg Paracetamol, 1000 mg\6 hours Fam® (Ketorolac), 30 mg

干预措施: Serratus Anterior Muscle Plane block (SAM block) (Procedure)

Paravertebral block

Active Comparator

Paravertebral block with general anesthesia. MARCAINE® 0.25%w/v solution for injection. DIPRIVAN® (propofol), 2 to 2.5 mg/kg NIMBEX® (cisatracurium besylate) Injection, 0.15-0.2 mg\Kg Fentanyl, 1-2 mic\Kg Paracetamol, 1000 mg\6 hours Fam® (Ketorolac), 30 mg

干预措施: Paravertebral Block (Procedure)

结局指标

主要结局

pain relief

时间窗: first postoperative day

reduction of pain intensities in the first postoperative day after breast surgery for cancer.

次要结局

  • opioid consumption(intraoperative and first postoperative day)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada M N Bashandy

Dr

National Cancer Institute, Egypt

研究点 (1)

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