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临床试验/CTRI/2025/11/097090
CTRI/2025/11/097090尚未招募4 期

Ultrasound guided erector spinae plane block versus retrolaminar block for post operative analgesia in patients under going modified radical mastectomy- a randomised controlled trial

Aarupadai veedu medical college and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月20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
60
试验地点
1
主要终点
To compare post operative analgesic efficacy of Erector Spinae Plane block and Retrolaminar Block in terms of the time taken to receive first rescue analgesic in patients undergoing Unilateral Modified Radical Mastectomy

研究概览

简要总结

Breast cancer is the most common cancer among women in India accounting for 32% of all women cancers.  The incidence is 35 per 100,000 women with 75000 new cases diagnosed and 40,000 deaths per year. Most commonly the surgical approach of choice is  Modified Radical Mastectomy (MRM),  due to it allowing for both the removal of the main tumor  mass and adjacent glandular tissue, which are suspected of infiltration and multifocality of the  process, and a sentinel axillary lymph node removal.(1) Acute pain after breast surgery may lead to the development of chronic persistent pain in women undergoing such procedures.  Blocking the nociceptive inputs through the intercostal nerves is important for the postoperative pain control after breast surgery, because cutaneous innervation of the breast is mainly derived from the intercostal nerves, along with supraclavicular nerves.(2)  Thoracic paravertebral block (TPVB) is widely used for providing post operative analgesia after breast surgery . This technique is having risk of   development of pneumothorax.(3) Erector Spinae Block targets the transverse process and mechanism of action is by spread of local anaesthetics into the paravertebral space and intercostal space. The Retrolaminar Block target lamina of vertebra and mechanism is by spread of local anaesthetic into the paravertebral space.(4)  So Retrolaminar Block and Erector Spinae Plane block are easier and safer alternative techniques to TPVB .

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Posted for unilateral Modified Radical Mastectomy under General anesthesia.

排除标准

  • ASA Class IV History of daily consumption of opiods and analgesics Previous surgery in thoracic vertrbral region BMI more than 30 Any infection at block site Previous allergy to drug used for the study.

结局指标

主要结局

To compare post operative analgesic efficacy of Erector Spinae Plane block and Retrolaminar Block in terms of the time taken to receive first rescue analgesic in patients undergoing Unilateral Modified Radical Mastectomy

时间窗: 24 hours

次要结局

  • To assess the intensity of pain during the first 24 hours using VAS score(To assess the total rescue analgesics consumption over 24 hours)

研究者

发起方
Aarupadai veedu medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vijikrishna V

Aarupadai veedu medical college and hospital

研究点 (1)

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