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临床试验/NCT04248608
NCT04248608已完成不适用

Perioperative Analgesic Modalities for Breast Cancer Surgeries

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年1月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Visual analogue score

研究概览

简要总结

The incidence of breast cancer is among women world wide, detection increased with introduction of mammography as a screening tool. surgical resection of breast cancer contributes to the generation of acute and chronic post mastectomy pain. This study aims at comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding pain control and possible side effects

详细描述

One of the most common types of cancer affecting women is breast cancer. Surgical resection is one of the main approaches applied for solid tumors. surgical approach for breast cancer involve the breast region. Various analgesic modalities are used for proper perioperative pain control. Morphine has always been considered as the gold standard analgesic, however opioids have multiple side effects. Several loco-regional techniques have been introduced for breast surgery pain management including serratus plane block (SPB) and erector spinae plane (ESP) block. In this study the investigators are comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding intraoperative and postoperative analgesia, time to first analgesic, any possible side effects

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, Outcomes Assessor)

入排标准

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

入选标准

  • female 18-65 years old patients undergoing modified radical mastectomy

排除标准

  • patient refusal, local infection at site of block coagulation defect abnormal kidney or liver functions

研究组 & 干预措施

erector spinae block

Experimental

Ultrasound guided erector spinae block with will be done after induction of intravenous anesthesia. After identification of trapezius, rhomboid major, and erector spinae muscles. The needle will be inserted in a cephalad-to-caudal direction until the tip contact transverse process and the needle tip is visualized in the plane deep to the erector spinae muscle. The needle tip position is confirmed by visualizing linear spread of test dose between the muscles after injection. A total dose of 25 mL of 0.25% bupivacaine will be injected.

干预措施: erector spinae block (Procedure)

serratus anterior block

Experimental

Ultrasound guided serratus anterior block will be done after induction of intravenous anesthesia. The serratus anterior, latissimus dorsi, and the intercostal muscles will be identified in the fourth and fifth intercostal level, an 18 G Tuohy needle will be advanced in the plane between the serratus anterior muscle and the intercostal muscles. A total dose of bupivacaine 25ml in a concentration of 0.25% will be administered under the serratus muscle after a test dose using an in-plane technique.

干预措施: serratus plane block (Procedure)

intravenous morphine

Active Comparator

intravenous morphine will be administrated in a dose of 0.1 mg per kg after induction of general anesthesia

干预措施: Morphine Sulfate (Drug)

结局指标

主要结局

Visual analogue score

时间窗: 24 hours

minimum score (0), maximum score (10) maximum score (10)

Total morphine consumption

时间窗: 24 hours

total morphine in mg received in first 24 hours postoprative

First time to receive morphine

时间窗: 24 hours

first time to receive morphine in the postoperative period (first 24 hours)

次要结局

  • mean arterial blood pressure(24 hours)
  • heart rate(24 hours)

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

Walaa Youssef Elsabeeny

lecturer of anesthesia and pain management

National Cancer Institute, Egypt

研究点 (1)

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