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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365555
• Other study ID #: SE2021-05967-01
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: April 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Linkoeping
• Contact: Daniel Leckström, MBBS
• Phone: +46704555507
• Email: daniel.leckstrom[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• Fascia Iliaca Compartment Block
Blind technique.
• Femoral Nerve Block
Ultrasound guided.

Drug:
• Ropivacaine
Ropivacaine dosed according to local guidelines.

Locations

Country	Name	City	State
Sweden	Akutmottagningen US Östergötland	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in reported pain score should be at least one whole unit on the numeric rating scale.	Measured 30 minutes after administered nerve block.
Secondary	Ratio of Failed Blocks	Defined by a failure to reduce reported pain 30 minutes after administered block by at least one whole unit on the numeric rating scale	Through study completion, an average of 1 year
Secondary	Rate of Complications	Comparing the rate of any reported complication between cohorts	Through study completion, an average of 1 year