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临床试验/NCT05365555
NCT05365555Unknown不适用

Analgesic Effect of Blind Fascia Iliaca Compartment Block Compared to an Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures

University Hospital, Linkoeping1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5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
发起方
入组人数
100
试验地点
1
主要终点
Mean Change from Baseline in Pain Scores on the Numeric Rating Scale (0 to 10, where 10 is Maximum Pain) at 30 minutes after Administration of Block, at Rest and During Active Hip Flexion

研究概览

简要总结

The goal of this study is to compare the analgesic effect of a blind fascia iliaca compartment block to an ultrasound-guided femoral nerve block in patients that present to the emergency department with hip fractures.

详细描述

Hip fractures often present to the emergency department and elderly, already fragile, patients are overrepresented. The pain associated with a hip fracture can be severe and have deleterious effects on the patient. Many studies, and a Cochrane review, have shown that a peripheral nerve block provides good pain relief and has many benefits compared to traditional pain relief, such as intravenous morphine. There is less consensus regarding which kind of nerve block, and which technique, is best to use. Many studies compared different kinds of nerve blocks to traditional methods, or more recently compared different kinds of ultrasound-guided techniques to each other.

This study proposes to compare the widely used technique of a blind fascia iliaca compartment block (FICB) to an ultrasound-guided femoral nerve block (FNB) that is currently being rolled out locally as an alternative. During the implementation period of this new clinical routine, it will be possible to compare the efficacy of FICB and FNB in reducing participant-reported pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adult emergency department patient over 18 years of age with a radiologically verified fracture classified as hip fracture that are eligible for a peripheral nerve block according to local guidelines

排除标准

  • Multi-system trauma
  • Isolated pelvic or diaphyseal femur fracture
  • Patients unable to communicate regardless of reason
  • Patients with contraindications to receiving a peripheral nerve block with an amide local anaesthetic according to local guidelines

研究组 & 干预措施

Fascia Iliaca Compartment Block (FICB)

Participants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks.

干预措施: Fascia Iliaca Compartment Block (Procedure)

Fascia Iliaca Compartment Block (FICB)

Participants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks.

干预措施: Ropivacaine (Drug)

Femoral Nerve Block (FNB)

Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation.

干预措施: Femoral Nerve Block (Procedure)

Femoral Nerve Block (FNB)

Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Mean Change from Baseline in Pain Scores on the Numeric Rating Scale (0 to 10, where 10 is Maximum Pain) at 30 minutes after Administration of Block, at Rest and During Active Hip Flexion

时间窗: Measured 30 minutes after administered nerve block.

Change in reported pain score should be at least one whole unit on the numeric rating scale.

次要结局

  • Rate of Complications(Through study completion, an average of 1 year)
  • Ratio of Failed Blocks(Through study completion, an average of 1 year)

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Wilhelms

MD, Emergency Department Head of Research

University Hospital, Linkoeping

研究点 (1)

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