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临床试验/CTRI/2025/11/097985
CTRI/2025/11/097985尚未招募4 期

To Evaluate the efficacy of PECS block as standalone anaesthesia technique for modified radical mastectomy- A Prospective interventional study.

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2025年12月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
47
试验地点
1

研究概览

简要总结

Breast cancer is the most common malignancy among women and Modified Radical Mastectomy is a frequently performed surgery. General anaesthesia, though standard, carries risks such as airway manipulation, postoperative nausea, vomiting, and hemodynamic instability, especially in high-risk patients. Pectoral nerve blocks (PECS I and II) provide a simple, ultrasound-guided regional technique that blocks pectoral, intercostobrachial, intercostal, long thoracic, and thoracodorsal nerves, reducing opioid use and recovery time. This prospective single-arm interventional study aims to evaluate the efficacy of PECS I and II blocks using 0.5 percent Ropivacaine with Dexamethasone under Dexmedetomidine sedation as the sole anaesthetic technique for Modified Radical Mastectomy. The primary outcome is successful completion of surgery without conversion to general anaesthesia. Secondary outcomes include intraoperative hemodynamic stability, intraoperative opioid requirement, and duration and quality of postoperative analgesia.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Patients classified as American Society of Anaesthesiologists (ASA) physical status I, II OR III.

排除标准

  • Patient refusal to participate or undergo regional anesthesia.
  • 2.Known allergy or hypersensitivity to local anesthetics or study drugs (Ropivacaine, dexamethasone, fentanyl, dexmedetomidine,bupivacaine).
  • 3.Infection at the block site or local skin pathology.
  • Coagulopathy or bleeding disorders 5.History of severe cardiovascular or respiratory instability contraindicating sedation or regional anesthesia.
  • Neurological disorders affecting pain perception or sensory mapping.
  • Patients on chronic opioid or sedative use, which may influence block efficacy.
  • 8.Inability to understand or communicate pain scores reliably (e.g., severe cognitive impairment).
  • 9.BMI more than 35 kg per m², as excessive adiposity may interfere with block performance or ultrasound visualization.

研究者

发起方
Department of Anaesthesiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kanta Bhati

Sardar Patel Medical College Bikaner, Rajasthan, India

研究点 (1)

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