跳至主要内容
临床试验/NCT03903224
NCT03903224已完成不适用

Effect of Combined Modified Pectoralis and Transversus Plane Blocks Versus Erector Spinae Block on Postoperative Analgesia Following Modified Radical Mastectomy

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
The total morphine consumption postoperative (mg)

研究概览

简要总结

The aim of this study is to compare the total morphine consumption in the first 24 hour postoperative between combined modified pectoralis block (PECS II) and transversus plane block versus erector spinae block in modified radical mastectomy.

详细描述

Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. Breast surgery is commonly performed as a part of the management of breast cancer, is associated with considerable acute postoperative pain. Ultrasound guided Regional anesthesia is recommended to be a part of multimodal analgesia in order to manage the acute post-operative pain. New techniques are proposed to give adequate control of postoperative analgesia with less opioid needs in the first day postoperative. They include pectoralis nerve modified pectoralis, and erector spinae blocks.

The investigators will compare Modified pectoralis nerve block (Pecs II) plus transversus thoracic muscle plane (TTP) block versus Erector spinae block on morphine consumption during first 24 h following modified radical mastectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18: 60 years old
  • ASA (American Society of Anesthesiologists) physical status I II
  • Female patients scheduled for modified radical mastectomy

排除标准

  • Patient refusal or inability to give informed consent
  • Subjects with a medical contraindication to regional anesthesia , such as coagulopathy, local infection or an allergy to local anesthetic
  • Body mass index (BMI) >35
  • Presence of psychiatric diseases
  • History of chronic chest wall pain or neuropathic disorders
  • Alcohol or drug abuse
  • Severe chest wall deformities

研究组 & 干预措施

Combined PECS II and TTP blocks (PT)

Active Comparator

Modified Pectoralis block (PECS II) : Using ultrasound we proceed to inject 10 ml of bupivacaine 0.25% between the pectoral muscles and 10 ml under Pmm above the serratus muscle.

Transversus Thoracic Plane block : 10 mL bupivacaine (0.25%) is injected between the transversus thoracic muscle and the internal intercostal muscle between the third and fourth left ribs connecting at the sternum.

干预措施: Combined Modified Pectoralis and Transversus Plane Blocks (Procedure)

Erector Spinae Block (E)

Active Comparator

Using ultrasound an echogenic 22-G block needle is inserted in-plane in a cranial-to-caudal direction until contact is made with the T5 transverse process. A total of 30 bupivacaine 0.25% is then injected while seeing the fluid lifting the erector spinae muscle off.

干预措施: Erector Spinae block (Procedure)

结局指标

主要结局

The total morphine consumption postoperative (mg)

时间窗: The first 24 hours postoperative.

Morphine consumption in mg

次要结局

  • Postoperative level of IL6 (interleukin 6) (pg/mL)(Two blood samples will be withdrawn from the patient. The first one is immediately preoperative and the second one after 24 hours postoperative)
  • Postoperative pain score by Verbal numeric rating scale(0, 2, 4, 8, 12, 24 hours postoperatively.)
  • Time to first request analgesia postoperative (min)(The first 24 hours postoperatively)
  • Arterial blood gas: Arterial blood gas: Arterial blood gases(Before surgery and 24 hours postoperative.)

研究者

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

Mohamed Bakri

Professor doctor of anaesthesia and ICU Faculty of Medicine - Assiut University

Assiut University

研究点 (2)

Loading locations...

相似试验