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临床试验/NCT05775393
NCT05775393招募中不适用

Effects of Adding Dexamethasone Plus Ketamine to Bupivacaine for Ultrasound Guided Serratus Plane Block as Analgesia in Major Breast Surgery

National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Post ooerative analgesia requirment

研究概览

简要总结

This randomized, double-blind trial included 60 female patients undergoing modified radical mastectomy. The study carried out at National Cancer Institute, cairo university after approval of the local ethical committee.

The study aiming to compare the analgesic efficiency of adding dexamethasone or ketamine plus dexamethasone to bupivacaine in ultrasound-guided serratus anterior plane block (SAPB) performed with modified radical mastectomy surgery.

详细描述

They will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes.

Group (A):

Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg).

Group (B):

Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All female patient undergoing modified radical mastectomy
  • Age from 20 to 60 years
  • ASA physical status I,II and III class

排除标准

  • Refusal for SAPB.
  • Defective coagulation.
  • Infection at the site of injection.
  • History of allergy to the study drugs

结局指标

主要结局

Post ooerative analgesia requirment

时间窗: 24 hours

Total post-operative morphine consumption over the first 24 hours post-operative and difference between two groups.

Time of first analgesic request

时间窗: 24 hours

The time to first request of analgesic postoperatively and difference between two groups.

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Fakher Mohamed Abdou

Dr

National Cancer Institute, Egypt

研究点 (2)

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