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临床试验/NCT04692857
NCT04692857已完成不适用

Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia

University Tunis El Manar1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
change in pain score on movement

研究概览

简要总结

participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.

for group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected

详细描述

participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.

A linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. After identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 .

pain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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
否

入选标准

  • •patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair .

排除标准

  • •inability or refusal to sign informed consent
  • •younger than 65 years
  • •BMI greater than 35 kg/m²
  • •presence of contraindications for regional nerve block or spinal anesthesia
  • •impaired cognition or dementia
  • •multiple fractures

研究组 & 干预措施

group 30

Experimental

participants received a supra inguinal fascia iliaca compartment block with 30 ml of 0.2% ropivacaine

干预措施: supra inguinal fascia iliaca block (Procedure)

group 40

Experimental

participants received a supra inguinal fascia iliaca compartment block with 40 ml of 0.2% ropivacaine

干预措施: supra inguinal fascia iliaca block (Procedure)

group 50

Experimental

participants received a supra inguinal fascia iliaca compartment block with 50 ml of 0.2% ropivacaine

干预措施: supra inguinal fascia iliaca block (Procedure)

结局指标

主要结局

change in pain score on movement

时间窗: before and 30 minutes after block placement

change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) during passive leg elevation to 15 degrees of the affected limb , before and 30 minutes after block placement

次要结局

  • change in pain score at rest(before and 30 minutes after block placement)
  • assessement of sensory block(30 minutes after block placement)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mechaal Benali

professor

University Tunis El Manar

研究点 (1)

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