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临床试验/NCT07683416
NCT07683416进行中(未招募)不适用

Dexmedetomidine as an Adjuvant to Bupivacaine for Serratus-Intercostal Versus Erector-Spinae Plane Block to Relieve Post-Mastectomy Pain

Zagazig University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年6月1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
进行中(未招募)
入组人数
70
试验地点
1
主要终点
The total opioid consumption.

研究概览

简要总结

A large number of patients undergoing major surgical procedures for the management of breast cancer complain of acute and chronic postoperative pain. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques, such as paravertebral block and thoracic epidural anaesthesia, have possible complications and technical difficulties. So, we will discuss adding dexmedetomidine as an adjuvant to bupivacaine for serratus-intercostal versus erector-spinae plane block to relieve post-mastectomy pain.

详细描述

Current pain management encompasses regional anaesthetic techniques and systemic administration of analgesia with a synergetic effect on pain. Regional analgesic techniques improve perioperative pain control, reduce opioid consumption and side-effects. We will investigate whether adding dexmedetomidine to bupivacaine for the serratus-intercostal plane block or the erector-spinae plane block during breast surgery could provide better intraoperative and postoperative analgesia, delay the time to first analgesic request, and reduce intraoperative and postoperative analgesic consumption.

研究设计

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

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Unilateral mastectomy operations.
  • Body mass index less than 35 kg per square meter.
  • American Society of Anesthesiologists physical status grade I-II.

排除标准

  • Patient refusal.
  • History of chronic pain therapy.
  • Infection at the injection site.

研究组 & 干预措施

Erector spinae plane block

Active Comparator

The patients will receive an ultrasound-guided erector spinae plane block after induction of general anaesthesia and before surgical incision.

干预措施: Erector spinae plane block (Procedure)

Serratus-intercostal plane block

Active Comparator

The patients will receive an ultrasound-guided serratus-intercostal plane block after induction of general anaesthesia and before surgical incision.

干预措施: Serratus-intercostal plane block (Procedure)

结局指标

主要结局

The total opioid consumption.

时间窗: The first 24 hours postoperative.

The total opioid consumption (morphine) in the first 24 hours postoperative.

次要结局

  • Time of the first rescue analgesia(The first 24 hours postoperative.)
  • Associated side effects(The first 24 hours postoperative.)
  • The static and dynamic visual analogue scale(The first 24 hours postoperative.)
  • Number of participants with procedure-related adverse events(The first 24 hours postoperative.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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