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临床试验/NCT04564326
NCT04564326Unknown不适用

Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

Zagazig University0 个研究点目标入组 51 人开始时间: 2021年1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
入组人数
51
主要终点
Comparison between the analgesic effect of both Pericapsular Nerve Group block and Fascia Iliaca block with VAS score.

研究概览

简要总结

Clinical controled trial to compare between pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

详细描述

Pain is a major problem that has to be dealt with in case of hip fracture, as it resembles an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy.

With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects. Of the many techniques to provide regional analgesia for hip fractures; fascia iliaca block was widely used with good results. In 2018 Pericapsular Nerve Group Block was introduced to provide regional analgesia for hip fractures with interesting results.

In this study the investigators are going to compare Pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

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
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient acceptance.
  • Accepted mental state of the patient.
  • Gender: both sexes.
  • Age above 65 years old.
  • Body mass index 18.5-35 kg/m
  • ASA physical status II and III.
  • Unilateral hip fracture assigned for surgical fixation.
  • Expected duration of surgery ≤ 3 hours.

排除标准

  • Associated trauma or multiple fractures.
  • Peripheral neuropathy.
  • Coagulopathy.
  • Infection at site of injection.
  • Allergy to the drugs used in the study.
  • Advanced kidney, liver or heart disease.

研究组 & 干预措施

Group C

Active Comparator

Patients will be assigned to receive opioids analgesia before spinal anesthesia in the form of intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between before positioning the patient for spinal anesthesia.

干预措施: Fentanyl (Drug)

Group P

Experimental

Patients will be assigned to receive Pericapsular Nerve Group Block (PENG Block) before positioning the patient for spinal anesthesia.

干预措施: Pericapsular nerve Group block (Procedure)

Group F

Experimental

Patients will be assigned to receive Fascia Iliaca Block (F.I Block) before positioning for spinal anesthesia.

干预措施: Facia Iliaca block (Procedure)

结局指标

主要结局

Comparison between the analgesic effect of both Pericapsular Nerve Group block and Fascia Iliaca block with VAS score.

时间窗: Baseline

Analysis of Visual Analogue Pain Score for both PENG block and FI block before and after each block during rest and movement to compare between their analgesic effect. The Visual Analogue Pain score is done by drawing a 10cm vertical line on a piece of paper with its limits "no pain" (0) on one side and "extreme pain" (10) on the other side. The patient will be asked to point where the pain (he/she) experiences lies on the line.

次要结局

未报告次要终点

研究者

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

Khaled Moustafa Magdy Nasr Mohamed

Principal Investigator

Zagazig University

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