Clinical trial NCT05365555: Blind Fascia Iliaca Compartment Block Compared to Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures
Official title: Analgesic Effect of Blind Fascia Iliaca Compartment Block Compared to an Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients in the emergency department with a radiologically verified hip fracture eligible for a peripheral nerve block according to local guidelines

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.

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

Primary outcomes:
measure: 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
timeFrame: Measured 30 minutes after administered nerve block.
Secondary outcomes:
measure: Ratio of Failed Blocks
timeFrame: Through study completion, an average of 1 year
measure: Rate of Complications
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Akutmottagningen US Östergötland
state: Östergötland
Study officials:
affiliation: University Hospital, Linköping
name: Daniel Wilhelms, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: