跳至主要内容
临床试验/CTRI/2022/09/045388
CTRI/2022/09/045388尚未招募不适用

A Prospective randomized single blinded study to compare the effect of serratus anterior plane block on postoperative analgesia after Mastectomy

Niraimozhi V1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年9月15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
102
试验地点
1
主要终点
To compare cumulative opioid consumption in both groups

研究概览

简要总结

The use of ultrasound in regional anaesthesia has facilitated the visualisation of anatomical structures,needle advancement and the spread of local anaesthetic.This has led to the further refinement of fascial plane blocks,in which the local anaesthetic is injected into a tissue plane rather than around individual nerves.Introduces by Blanco et al,Serratus Anterior Plane block is a novel form of ultrasound guided regional anaesthesia fascial plane block that can achieve paraesthesia of the hemithorax.This study evaluates the analgesic efficacy of Serratus Anterior Plane block on acute pain after Mastectomy.The study participants are divided into two groups. Group-A is control group where no block will be given, Group-B is Serratus Anterior Plane block group, these participants after intubation they will be getting block under ultrasound guidance.At the end of the surgery, post extubation following transfer to PACU,both groups will be getting Intravenous Inj.Morphine using Patient Controlled Analgesia pump. The primary outcome of this study is to compare cumulative opioid consumption in both groups. The secondary outcome is to assess the analgesic efficacy using Visual Analog Scale.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • ASA status I to III patients posted for Mastectomy.

排除标准

  • 1.Refusal to participate in the study 2.Age less than 18 years.
  • 3.ASA class IV and V 4.Known coagulation disorders.
  • 5.Allergy to Local anaesthetics.
  • 6.Unconscious or mentally incompetent prior to surgery 7.Pregnancy 8.Hemodynamic instability (SBP less than 90mmHG,MAP less than 60mmHG).

结局指标

主要结局

To compare cumulative opioid consumption in both groups

时间窗: 24 hours post surgery

次要结局

  • To assess analgesic efficacy using Visual Analog Scale(Visual Analog Scale score at 15mins,1hr,2hr,4hs,8hr,12hr,16hr,20hr and 24hr intervals shall be monitored)

研究者

发起方
Niraimozhi V
申办方类型
Other [self]

研究点 (1)

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