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临床试验/NCT05224310
NCT05224310已完成不适用

Comparing the Quality of Analgesia With Ultrasound-guided Pectoral Nerve Block and Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy

Suez Canal University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月1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
50
试验地点
2
主要终点
The first request for analgesia

研究概览

简要总结

The use of pectoral nerve block (PECSB) is a new technique during modified radical mastectomy MRM.

The Serratus anterior Plane (SAP) Block has been proven to be an effective component of multimodal analgesia regimens for a variety of thoracic procedures including MRM.

In this study, the investigators will assess and compare the quality of analgesia with ultrasound-guided Serratus plane block and pectoral nerve block in patients undergoing modified radical mastectomy MRM.

详细描述

Breast cancer is the most common cause of cancer death among women worldwide. In Egypt, breast cancer is the most common malignancy in women, accounting for 38.8% of cancers in this population. It is estimated that the breast cancer mortality rate is around 11%, being the second cause of cancer-related mortality after liver cancer.

According to the European network of cancer registries, most breast cancer patients require breast surgery to remove the primary tumour and axillary staging or dissection. Approximately 40% of these patients will experience clinically significant acute postoperative pain. Furthermore, acute postoperative pain is an important risk factor for the development of persistent chronic postoperative pain in women after breast surgery.

Acute postoperative pain is associated with increased comorbidity and hospital stay length; as it will affect respiratory functions, chest wall compliance, cardiac output, blood pressure, cardiac workload, metabolism, oxygen consumption, decreased tone of gastrointestinal and urinary tracts and marked increases in catabolic hormones (catecholamine, adrenocorticotrophic hormone, antidiuretic hormone, glucagon, and aldosterone) while decreasing anabolic hormones such as insulin and testosterone.

It has been reported that up to half of the patients have a negative impact of pain on their activities and up to one-quarter report moderate to high impact on their daily activities at home and work. Thus, more effective treatment modalities are used for decreasing postoperative pain in mastectomy patients include; patient-controlled analgesia PCA, thoracic epidural, and thoracic paravertebral block.

While the key requirement for successful regional anaesthetic blocks is ensuring optimal distribution of local anaesthetic around nerve structures, ultrasound guidance enables the anaesthetist to secure an accurate needle position and to monitor the distribution of the local anaesthetic in real-time.

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 (Participant)

入排标准

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

入选标准

  • Adult, female patients,
  • ASA physical status I, II, and III
  • Aged older than 18 years
  • Scheduled for modified radical mastectomy surgery under general anaesthesia.

排除标准

  • Any known allergies to the study drugs.
  • Apparent anatomical abnormalities or infections in the serratus region.
  • Bleeding disorders e.g. thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
  • Patients on chronic pain medications or regularly receiving analgesics.
  • Pregnant or breastfeeding patients.

结局指标

主要结局

The first request for analgesia

时间窗: immediately at the end of 24 hours post operatively

the time from the completion of the block to the time of the first request for analgesia.

次要结局

  • Post-operative pain(immediately postoperatively 0,2,4,6,8,12,14,16,18,20,22,and 24 h after surgery at rest)

研究者

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

Abdelrhman Alshawadfy

Lecturer of anesthesia and intensive care

Suez Canal University

研究点 (2)

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