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临床试验/NCT06371625
NCT06371625已完成不适用

Ultrasound Guided Transversus Thoracic and Pectoral Nerve Block Versus Pectoral Nerve Block in Modified Radical Mastectomy

Ahmed Mohamed Soliman5 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
5
主要终点
total morphine consumption

研究概览

简要总结

Interfascial blocks score over regional anesthetic techniques such as Transversus Thoracic Plane Block and Pectoral Nerves (PECS) Block as they have no risk of sympathetic blockade, intrathecal or epidural spread, which may lead to hemodynamic instability and prolonged hospital stay. The transversus thoracic muscle plane block (TTP) block is a newly developed regional anesthesia technique which provides analgesia to the anterior chest wall. First described by Ueshima et al. in 2015, the TTP block is a single-shot nerve block that deposits local anesthetic in the transversus thoracic muscle plane between the internal intercostal and transversus thoracic muscles. TTP block targets the anterior branches of the intercostal nerves (T2-6).

Pectoral plane blocks are recently described . PECS block involves deposition of local anesthetic drug between muscle planes. PECS I block, between Pectoralis Major and Minor at third rib level, and PECS II block, the drug is deposited between Pectoralis minor and Serratus anterior muscle.

The pectoral nerves (PECS) block provides analgesia of the lateral mammary region, the intercostobrachial and lateral cutaneous branches of the intercostal nerves (T2-T6), the medial cutaneous nerve of the arm and forearm, and the long thoracic and thoracodorsal nerves. The modified PECS block produces excellent analgesia and can be used to provide balanced anesthesia.

详细描述

Background and Rationale:

Breast cancer is one of the common malignancies among women. Surgical resection of the primary tumor with axillary dissection is one of the main modalities of breast cancer treatment. The most common modality for anesthesia is general anesthesia with or without regional blocks. It has been reported that 40% of females report moderate to severe pain in the immediate post-operative period after breast cancer surgery. Acute post-surgical pain leads to delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay.

It is also an important factor leading to the development of chronic persistent post-operative pain in almost half of the patients. Post-operative pain, stress and use of morphine have been elucidated as factors responsible for increased risk of metastasis. Hence, effective perioperative pain management of patients undergoing breast surgery is essential. Regional blocks have been considered one of the modalities for effective perioperative pain control. They have an opioid-sparing effect and allow early mobilization and early discharge from the hospital.

Interfascial blocks score over regional anesthetic techniques such as Transversus Thoracic Plane Block and Pectoral Nerves (PECS) Block as they have no risk of sympathetic blockade, intrathecal or epidural spread, which may lead to hemodynamic instability and prolonged hospital stay. The transversus thoracic muscle plane block (TTP) block is a newly developed regional anesthesia technique which provides analgesia to the anterior chest wall. First described by Ueshima et al. in 2015, the TTP block is a single-shot nerve block that deposits local anesthetic in the transversus thoracic muscle plane between the internal intercostal and transversus thoracic muscles. TTP block targets the anterior branches of the intercostal nerves (T2-6).

Pectoral plane blocks are recently described . PECS block involves deposition of local anesthetic drug between muscle planes. PECS I block, between Pectoralis Major and Minor at third rib level, and PECS II block, the drug is deposited between Pectoralis minor and Serratus anterior muscle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 11 per group. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.

入排标准

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

入选标准

  • female patients.
  • type of surgery: MRM
  • ASA I, II, III
  • BMI >20 kg/m2 and <35 kg/m2

排除标准

  • BMI <20 kg/m2 and >35 kg/m2
  • known sensitivity or contraindication to drugs used
  • history of psychological disorders.
  • patient refusal
  • pregnancy
  • contraindication to regional anesthesia e.g. local sepsis, pre-existing peripheral neuropathy and coagulopathy

结局指标

主要结局

total morphine consumption

时间窗: 24 hours postoperatively

total morphine consumption as iv analgesic

次要结局

  • visual analogue scale "VAS score"(24 hours postoperative)
  • mean blood pressure(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively)
  • heart rate(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively)
  • first analgesic dose(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively)

研究者

发起方
Ahmed Mohamed Soliman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Mohamed Soliman

lecturer of anesthesia

National Cancer Institute, Egypt

研究点 (5)

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