跳至主要内容
临床试验/CTRI/2022/10/046523
CTRI/2022/10/046523尚未招募4 期

To study the long term benefits of Ultrasound guided Erector Spinae Plane block on Post Mastectomy Pain Syndrome in patients undergoing breast surgery: A Randomized Controlled Trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年10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
130
试验地点
1
主要终点
•To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire

研究概览

简要总结

The peri-operative pain management appeared as major point to reduce the risk of chronic pain after surgery. A potential target for an interventional procedure for chronic pain after treatment for breast cancer is the Erector Spinae Plane (ESP) block. Here, local anaesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerve dermatomes from vertebral C5 to T6. Local anaesthetic expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally. This block can be given unilaterally for breast surgeries with anaesthesia similar to that of thoracic epidural block without its hemodynamic side effects.  In this study we will compare ESP block with control for prevention of post mastectomy pain syndrome.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 20-65 years American Society of Anesthesiologists (ASA) physical status I-II Scheduled for elective surgery for breast cancer (unilateral surgical procedure).

排除标准

  • 1.Patient refusal 2.Infection of the skin at the site of the needle puncture 3.Chronic infection 4.Known allergies to any of the study drugs 5.Coagulopathy 6.Patient already receiving analgesics 7.Mentally challenged patients 8.Liver and renal dysfunction.

结局指标

主要结局

•To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire

时间窗: •To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire

次要结局

  • i.24 hours postoperative consumption of opioids(ii.Intraoperative and postoperative hemodynamic changes)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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