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Clinical Trials/NCT05365555
NCT05365555
Unknown
Not Applicable

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

University Hospital, Linkoeping1 site in 1 country100 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Fascia Iliaca Compartment Block
Conditions
Hip Fractures
Sponsor
University Hospital, Linkoeping
Enrollment
100
Locations
1
Primary Endpoint
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
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
April 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Linkoeping
Responsible Party
Principal Investigator
Principal Investigator

Daniel Wilhelms

MD, Emergency Department Head of Research

University Hospital, Linkoeping

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Fascia Iliaca Compartment Block (FICB)

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

Intervention: Fascia Iliaca Compartment Block

Fascia Iliaca Compartment Block (FICB)

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

Intervention: Ropivacaine

Femoral Nerve Block (FNB)

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

Intervention: Femoral Nerve Block

Femoral Nerve Block (FNB)

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

Intervention: Ropivacaine

Outcomes

Primary Outcomes

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

Time Frame: Measured 30 minutes after administered nerve block.

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

Secondary Outcomes

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

Study Sites (1)

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