跳至主要内容
临床试验/CTRI/2025/01/079032
CTRI/2025/01/079032尚未招募不适用

Erector spinae plane block for post operative analgesia in modified radical mastectomy. A randomised prospective study.

Dr Gali Nikhila Naidu1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To study the efficacy of Erector spinae plane block for post-operative analgesia in modified radical mastectomy.

研究概览

简要总结

This is a randomized prospective study evaluating erector spinae plane block for postoperative analgesia in modified radical mastectomy.

Patients are allocated into two groups. Group E patients will receive general anesthesia and erector spinae plane block with a total of 25 ml of 0.25% bupivacaine and dexamethasone 4mg through a 23 G Quincke Babcock spinal needle under ultrasound guidance, while Group C patients will receive only general anesthesia.

The study’s primary objective is to assess the efficacy of Erector spinae plane block for postoperative analgesia using a visual analog pain score. The secondary objective is to assess the Time for the first rescue analgesia and the Total dose requirement of the rescue analgesic.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • ASA I & II patients
  • Patients with Body Mass Index (BMI) between 18.5 and 30 kg per m2
  • Patients who have given consent.

排除标准

  • Patients refusal
  • Repeat surgery, pre existing infection at block site
  • Coagulation disorder
  • Preoperative hypotension (mean arterial BP less than 50 mmHg), Bradycardia (hear rate less than 45 BPM), Dysrhythmia, Psychiatric illness.
  • Pre existing neurological deficits.
  • Known allergy to study drugs.
  • Patients belonging to ASA physical status grade III and IV.

结局指标

主要结局

To study the efficacy of Erector spinae plane block for post-operative analgesia in modified radical mastectomy.

时间窗: 12 hours

次要结局

  • 1.Time for first rescue analgesia.(2.Total dose requirement of rescue analgesic.)

研究者

发起方
Dr Gali Nikhila Naidu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gali Nikhila Naidu

Kidwai Memorial Institute of Oncology

研究点 (1)

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