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临床试验/NCT05076773
NCT05076773已完成不适用

A Comparative Study Between Ultrasound-guided Thoracic Paravertebral Block, Pectoral Nerves Block, and Erector Spinae Block for Pain Management in Cancer Breast Surgeries. A Randomized Controlled Study

Menoufia University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).

研究概览

简要总结

Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, 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 physical status classification class I or II
  • Age group 18 - 60 years of the female gender
  • Patients undergoing breast cancer surgeries

排除标准

  • Patient refusal
  • History of hypersensitivity to local anesthetics
  • Bleeding disorders or patients receiving anticoagulants
  • Spine or chest wall deformities
  • Local infection at the site of injection.

研究组 & 干预措施

Erector spinae block Group (C)

Active Comparator

Will receive erector spinae block

干预措施: IV morphine (Drug)

Paravertebral block Group (A)

Active Comparator

Will receive thoracic paravertebral block

干预措施: Ultrasound guided block (Procedure)

Control Group (D)

Placebo Comparator

Patient will receive opioid only for management of their perioperative pain

干预措施: IV morphine (Drug)

Paravertebral block Group (A)

Active Comparator

Will receive thoracic paravertebral block

干预措施: IV morphine (Drug)

Pectoral block Group (B)

Active Comparator

Will receive pectoral 1 and 2 block

干预措施: Ultrasound guided block (Procedure)

Pectoral block Group (B)

Active Comparator

Will receive pectoral 1 and 2 block

干预措施: IV morphine (Drug)

Erector spinae block Group (C)

Active Comparator

Will receive erector spinae block

干预措施: Ultrasound guided block (Procedure)

结局指标

主要结局

The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).

时间窗: 0-24o minutess

minutes

次要结局

  • Postoperative nausea and vomiting (PONV)(48 hours)
  • Postoperative pain(48 hours)
  • Total morphine consumption(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

kareem Mikhamer

Assistant fellow

Menoufia University

研究点 (1)

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