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临床试验/NCT06837506
NCT06837506已完成不适用

Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy: A Randomized Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月20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
Total morphine consumption

研究概览

简要总结

This study aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy.

详细描述

Effective postoperative analgesia is crucial for enhancing recovery and patient satisfaction following major surgical procedures, such as total abdominal hysterectomy (TAH).

Rectus sheath block (RSB), an ultrasound-guided regional anesthesia technique, involves the injection of local anesthetic into the rectus sheath, providing analgesia to the anterior abdominal wall. RSB is used to block the sensory nerves of the anterior abdominal wall and thereby contributing to pain relief after lower abdominal surgeries.

Intrathecal morphine (ITM) provides a highly effective method of analgesia by delivering the medication directly into the cerebrospinal fluid (CSF).

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age: 18 - 65 years old.
  • •American Society of Anesthesiologists (ASA) physical status (I -II).
  • •Patients undergoing open total abdominal hysterectomy.

排除标准

  • •Hepatic, renal, or cardiac disease.
  • •Any known allergy to local anesthetic.
  • •Physical or mental conditions which may vague measuring postoperative pain following surgery.
  • •History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.

研究组 & 干预措施

Rectus sheath block group

Experimental

Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.

干预措施: Rectus sheath block (Drug)

Intrathecal morphine group

Experimental

Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.

干预措施: Intrathecal morphine (Drug)

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

Morphine will be administered if the visual analog scale (VAS) score is ≥ 4.

次要结局

  • Time to the first request for the rescue analgesia(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Degree of patient satisfaction(24 hours postoperatively)
  • Time of hospital discharge(28 days postoperatively)
  • Degree of sedation(Intraoperatively)
  • Incidence of adverse events(24 hours postoperatively)

研究者

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

Sarah Ahmed

Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Ain Shams University

研究点 (1)

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