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临床试验/CTRI/2024/09/073625
CTRI/2024/09/073625尚未招募2/3 期

Comparison of ultrasound guided superficial versus deep Serratus anterior plane block in providing postoperative analgesia after mastectomy A prospective randomized double blinded trial

SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年9月19日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
130
试验地点
1
主要终点
Cumulative 24 hour IV PCA morphine consumption in both the groups

研究概览

简要总结

Breast surgery is becoming more common in women. Surgical incisions in the breast and axillary areas cause severe discomfort, with a high frequency of acute pain escalating to chronic pain in 25% to 60% of patients. The serratus anterior plane block (SAP block) is a safe and simple block that is performed under ultrasound guidance by administering local anesthetic in the plane between the serratus anterior and latissimus dorsi muscles (superficial SAP block) or between the serratus anterior muscle and the ribs at the mid-axillary line between the 4th and 5th ribs(deep SAP block). Dexmedetomidine can extend the duration of action of local anesthetics. Dexmedetomidine is a strong sedative, analgesic, and has anaesthetic properties when used in general anaesthesia.

The purpose of this study was to investigate the difference in postoperative cumulative 24 hour opioid consumption and postoperative analgesia between superficial and deep SAP block in patients undergoing unilateral mastectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • American society of Anaesthesiologists (ASA) status I-III
  • Female patients posted for unilateral mastectomy.

排除标准

  • Allergy to LA
  • Coagulopathy
  • Local infection at block site
  • Preoperative opioid use
  • Inability to provide informed consent
  • Patient refusal to participate in the study.

结局指标

主要结局

Cumulative 24 hour IV PCA morphine consumption in both the groups

时间窗: 24 HOURS

次要结局

  • VAS scores with rest and movement(Time to first rescue analgesic)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR KAMAAL MOHIDEEN KHAN B

Sri Ramachandra Institute Of Higher Education And Research

研究点 (1)

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