跳至主要内容
临床试验/CTRI/2019/04/018394
CTRI/2019/04/018394尚未招募不适用

Comparision of general anesthesia with ultrasound guided pecs block and serratus anterior plane block using bupivacaine and dexmeditomidine versus general anesthesia alone in modified radical mastectomy patients

SRI RAMAKRISHNA HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年9月30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
60
试验地点
1
主要终点
1.To determine the time for 1st rescue analgesia.

研究概览

简要总结

BACKGROUND AND AIMS: Breast cancer is the most common cause in women worldwide with morethan 1 million new cases diagnosed every year. Acute post operative pain following mastectomy remains a challenge for the anaesthesiologist despite a range of treatment options available. The present study aimed to compare the post operative analgesic efficacy of PECS block and serratus anterior plane block performed under ultrasound with our standard practise of opioids and non-steroidal anti-inflammatory drugs for mastectomy. 

METHODS: Randomised controlled study to be conducted in our hospital after obtaining ethical clearence 60 adult female patients posted for elective unilateral modified radical mastectomy to be divided in to 2 groups as follows. Group S- general anesthesia with out block. Group BD- general anesthesia with PECI, PECII,and Serratus anterior plane block with 30ml of 0.25% Bupivacaine with 0.5mcg/kg bodyweight of Dexmeditomidine.Primary outcome to be measured as patient reported pain intensity using VAS at rest.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • 1.ASA I and II patients.
  • 2.patients coming for elective breast surgeries.
  • 3.patients who provide consent for the study.

排除标准

  • 1.ASA III and above.
  • 2.patient refusal.
  • 3.patients allergic to study drug.
  • 4.patient who are pregnant, patient on any antidepressant, antipsychotics drugs.
  • 5.prior breast surgeries except for dianostic purpose.

结局指标

主要结局

1.To determine the time for 1st rescue analgesia.

时间窗: 30/3/2019

2.Total rescue analgesia consumed over 24 h period was recorded.

时间窗: 30/3/2019

次要结局

  • 1.Incidence of hypotension and bradycardia.(2.Incidence of PONV and pruritus)

研究者

发起方
SRI RAMAKRISHNA HOSPITAL
申办方类型
Private hospital/clinic

研究点 (1)

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