跳至主要内容
临床试验/NCT06019754
NCT06019754已完成不适用

The One-Point Puncture Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Orthopedic Surgeries

Zagazig University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Total intraoperative and postoperative opioid consumption

研究概览

简要总结

lumbosacral plexus block (LSPB) has been widely applied in orthopedics departments due to its advantages, including reduction in the application of opiates, decreasing the occurrence of acute pain, promoting early activation, and shortening the time of hospital stay. LSPB is a peripheral regional technique of anesthesia and analgesia, that provides a block of the main components of the lumbosacral plexus.

详细描述

Traditional ultrasound-guided lumbar plexus block combined with sacral plexus block requires separate blocks at different sites, requiring the lateral decubitus or prone position, which may be suboptimal in patients with severe pain. we present an anterior approach for combined lumbar and sacral plexus blocks with a one-point puncture.

研究设计

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

盲法说明

Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II.
  • patients diagnosed with unilateral lower limb fracture who necessitate intraoperative tourniquet application
  • patients who have severe pain hindering changing their position or patients who have spinal fractures or refusing spinal anesthesia.
  • Ideal body weight > 60 kg
  • patients with the capability of communication

排除标准

  • puncture site infection
  • patients with coagulation disorders
  • patients who refuse to participate or withdraw due to personal reasons
  • allergy to local anesthetics.
  • past surgery at the site of the block
  • hip ankylosis
  • drug abuse
  • Body mass index ≥ 35 kg/m2
  • peripheral vascular insufficiency
  • use of alpha or beta blocker agents
  • Nerve injury of the affected lower limb

结局指标

主要结局

Total intraoperative and postoperative opioid consumption

时间窗: Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative

The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 24 hours postoperative will be calculated.

次要结局

  • (NRS) score assessment pre-block, 30 min post-block , and postoperatively in the recovery room, and then it will be repeated 3 h, 6h, 12h, and 24, hours(preoperative and postoperatively pain (NRS) score assessment for 24 hours)
  • Block success assessment using perfusion index (PI) before and after performing the block(Recording Perfusion index readings at baseline and 10, 20, 30 min. post block)

研究者

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

Naglaa Fathy Abdelhaleem Abdelhaleem

Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Zagazig University

研究点 (2)

Loading locations...

相似试验

Combined Lumbar and Sacral Branches Block Through... | 临床试验