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

• Conditions: Hip Fractures
• Interventions: Procedure: Fascia Iliaca Compartment Block; Procedure: Femoral Nerve Block; Drug: Ropivacaine

• Registration Number: NCT05365555
• Lead Sponsor: University Hospital, Linkoeping

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.

Study Timeline

• Study First Submitted: 2022-04-27
• Status Verified: 2022-05
• Study Start: 2022-05-01
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fascia Iliaca Compartment Block (FICB)	Fascia Iliaca Compartment Block	Participants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks.
Fascia Iliaca Compartment Block (FICB)	Ropivacaine	Participants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks.
Femoral Nerve Block (FNB)	Femoral Nerve Block	Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation.
Femoral Nerve Block (FNB)	Ropivacaine	Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Rate of Complications	Through study completion, an average of 1 year	Comparing the rate of any reported complication between cohorts
Ratio of Failed Blocks	Through study completion, an average of 1 year	Defined by a failure to reduce reported pain 30 minutes after administered block by at least one whole unit on the numeric rating scale

Trial Locations

Locations (1)

Akutmottagningen US Östergötland; 🇸🇪 Linköping, Östergötland, Sweden