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临床试验/NCT03063073
NCT03063073已完成3 期

Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study

South Egypt Cancer Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
I.V patient controlled analgesia (PCA) morphine consumption

研究概览

简要总结

The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).

详细描述

60 patients scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfascial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • ASA I - II patients
  • weight 50- 100 kg
  • age 18-60 years

排除标准

  • History of bleeding diathesis
  • Relevant drug allergy
  • Opioid dependence
  • Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study

研究组 & 干预措施

Dexmedetomidine Injection [Precedex]

Active Comparator

ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection [Precedex] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

Group I (Bupivacaine group)

Placebo Comparator

ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscle

干预措施: Bupivacaine Injection [Marcaine] (Drug)

Dexmedetomidine Injection [Precedex]

Active Comparator

ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection [Precedex] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

干预措施: Bupivacaine Injection [Marcaine] (Drug)

结局指标

主要结局

I.V patient controlled analgesia (PCA) morphine consumption

时间窗: 48 hours postoperative

the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative

次要结局

  • pain relief(48 hour)

研究者

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

Mohammed Farghaly Abd El hamid Ahmed

assisstant lecturer

South Egypt Cancer Institute

研究点 (1)

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