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临床试验/NCT04920669
NCT04920669已完成不适用

Can Dexmedetomidine Improve the Analgesic Duration and Efficacy of Erector Spinae Plane Block in Breast Cancer Surgeries?

Mohamed Elsayed Hassan1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Time to first request of analgesia

研究概览

简要总结

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

详细描述

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are numerical rating scales and incidence of opioid side effects.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Female, aged (18-70) years
  • Belongs to American Society of Anaesthesiologists physical status class II.
  • Scheduled for breast cancer surgeries.

排除标准

  • Patient refusal.
  • Local infection at the site of the block.
  • Cardiac dysfunction (ejection fraction <45%).
  • Preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (PCA) device.
  • Allergy to one of the study drugs.
  • Pregnancy.
  • Coagulopathy (PC <60% and platelet count<100.000).

结局指标

主要结局

Time to first request of analgesia

时间窗: The first postoperative day

Time from recovery of anesthesia till first request for analgesia to relive pain.

次要结局

  • Total morphine consumption in first postoperative 24 hours(First 24 postoperative hours)
  • Intraoperative fentanyl requirement(During anesthesia)
  • Numerical rating scale(The first 24 postoperative hours)

研究者

发起方
Mohamed Elsayed Hassan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Elsayed Hassan

assistant professor of anesthesia and pain relief

National Cancer Institute, Egypt

研究点 (1)

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