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临床试验/NCT06580704
NCT06580704已完成不适用

Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients: A Randomized Clinical Study

Tanta University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年8月31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
130
试验地点
1
主要终点
Incidence of failure

研究概览

简要总结

This study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients.

详细描述

The lower limb surgeries are associated with acute postoperative pain and require long-term analgesia. Regional anesthesia is often used to prevent postoperative pain. Ultrasound-guided regional anesthetic approaches provide a simple intraoperative pathway that lowers pain scores with less impact on the respiratory or cardiovascular system.

Psoas compartment block (PCB) is a peripheral regional technique of anesthesia, which provides a block of the main components of the lumbar plexus - the femoral, lateral cutaneous nerve of the femur and sciatic nerve. In combination with the sciatic nerve block, the psoas compartment block provides effective anesthesia of the entire lower extremity, with better hemodynamic stability.

The erector Spinae plane block (ESPB) is a novel regional block technique primarily introduced in 2016 for managing severe neuropathic pain.

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
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • History of allergy to local anesthetics.
  • Bleeding tendency.
  • Coagulopathy.
  • Anticoagulant therapy.
  • Pre-existing psychological, neurologic, and spinal cord diseases.
  • Previous back surgery.
  • Infection or mass at the site of the block.
  • Chronic analgesic therapy.
  • Severe cardiac or renal diseases.

研究组 & 干预措施

Lumbosacral Erector Spinae Plane Block

Experimental

Patients will receive ultrasound-guided lumbosacral erector spinae plane block.

干预措施: Lumbosacral Erector Spinae Plane Block (Drug)

Psoas Muscle Compartment With Sciatic Nerve Block

Experimental

Patients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block.

干预措施: Psoas Muscle Compartment With Sciatic Nerve Block (Drug)

结局指标

主要结局

Incidence of failure

时间窗: Intraoperatively

Incidence of failure will be recorded. After 30minutes, the pinprick test will be performed. If pain persists, the patient will be excluded.

次要结局

  • Hear rate(Every 15 minutes till the end of surgery (up to 2 hours))
  • Mean arterial pressure(Every 15 minutes till the end of surgery (up to 2 hours))
  • Duration of analgesia(Till the first request of rescue analgesic drug (up to 24 hours after surgery))
  • Degree of pain(24 hours postoperatively)
  • Degree of patient satisfaction(24 hours postoperatively)
  • 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

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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