跳至主要内容
临床试验/CTRI/2024/02/063317
CTRI/2024/02/063317尚未招募Phase 3 4

A comparative study to evaluate analgesic efficacy of pre operative and intraoperative pectoralis nerve block for patients undergoing Modified Radical Mastectomy

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月11日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
70
试验地点
1
主要终点
To evaluate the effect of pre operative USG guided and intra operative pectoral nerve block with 30ml 0.25% ropivacaine each for pain relief for patients undergoing MRM.e pre operative USG guided and intraoperative under vision pectoral nerve block.

研究概览

简要总结

Post operative pain associated with modified radical mastectomy in breast cancer surgery is a growing concern. Various modalities for regional anaesthesia have been studied and practiced for the same. One such latest method is pectoralis nerve block, which is found to be efficient and effective.  The aim and objective is to evaluate the analgesic efficacy of pre operative ultrasound (USG) guided pectoralis nerve block  and intra operative pectoralis nerve block in modified Radical mastectomy (MRM) under General anaesthesia (GA).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • Patients undergoing unilateral modified radical mastectomy under general anesthesia.
  • Age group between 18 to 65 years of either gender, giving valid informed and written consent.
  • American Society of Anaesthesiologist grade I and II.

排除标准

  • Patients with any contraindication to regional anesthesia.
  • Patients with a history of anaphylaxis to local anaesthetics and allergy to the study drugs.
  • Pregnant or lactating patients.

结局指标

主要结局

To evaluate the effect of pre operative USG guided and intra operative pectoral nerve block with 30ml 0.25% ropivacaine each for pain relief for patients undergoing MRM.e pre operative USG guided and intraoperative under vision pectoral nerve block.

时间窗: Outcome will be assessed at the end of study of 1.5 yrs.

Analgesic efficacy evaluated with VAS score and the duration until first rescue analgesic given.

时间窗: Outcome will be assessed at the end of study of 1.5 yrs.

次要结局

  • The need for rescue analgesic after the USG guided & undervision pec block(Outcome will be assessed with in 24 hours of pec block)

研究者

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

Famna Faisal C H

Guru Gobind Singh Medical College Faridkot

研究点 (1)

Loading locations...

相似试验