Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture

NCT02433548 — Phase 4, Completed, 30 participants, Centre Hospitalier Universitaire Vaudois

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Registry	NCT02433548
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	30 (Actual)
Sponsor	Centre Hospitalier Universitaire Vaudois (Other)
Conditions	Femoral Neck Fracture
Interventions	Fascia iliaca block, Sham injection (Procedure)
Dates	start 2014-10-01, primary completion 2016-08-01, completion 2016-08-01, first posted 2015-05-05, last updated 2016-09-27
Locations	1 site in Switzerland

-Summary

Femoral neck fracture is very common in the elderly and can produce severe to moderate pain. As this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain.

Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.

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+Detailed description

The objective of this trial is to compare the fascia iliaca block with a sham injection on patients arriving in the emergency department with a femoral neck fracture.

The fascia iliaca block will be performed with an anatomical landmark technique and a volume of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL will be injected.

+Arms and interventions

Arm	Type	Interventions	Description
Fascia iliaca block	Experimental	Procedure: Fascia iliaca block	Fascia iliaca block (Injection of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®)
Sham injection	Sham comparator	Procedure: Sham injection	No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention)

Fascia iliaca block (Procedure): injection of 30 mLs below the fascia iliaca
Sham injection (Procedure): subcutaneous of 5 cc of normal saline

+Outcome measures

Primary outcomes

Pain scores at rest [45 minutes after the injection]

Secondary outcomes

Pain scores at rest [60 min, 4h, 8h, 12h, 24h after the injection]
Pain scores on movement [60 min, 4h, 8h, 12h, 24h after the injection]
Morphine consumption [60 min, 4h, 8h, 12h, 24h after the injection]
Length of stay [up to 3 weeks]

+Eligibility

Sex: All, ages: 18 Years to 99 Years

Inclusion Criteria:

\- patients with femoral neck fracture in the emergency department

Exclusion Criteria:

* presence of demencia
* body weight less than 40kg
* presence of a cancer or patients receiving chemotherapy
* allergy to local anaesthetics

+Locations (1)

Facility	City	Country	Status
CHUVaudois	Lausanne, Canton of Vaud	Switzerland

+Publications

Results publication: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3. PMID 33238043
Results publication: Pasquier M, Taffe P, Hugli O, Borens O, Kirkham KR, Albrecht E. Fascia iliaca block in the emergency department for hip fracture: a randomized, controlled, double-blind trial. BMC Geriatr. 2019 Jul 1;19(1):180. doi: 10.1186/s12877-019-1193-0. PMID 31262265

+Investigators

Eric Albrecht, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois

My Notes

Public

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