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

NCT02433548 | Completed Phase 4

• 1 other identifier: 318/14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Femoral Neck Fracture

Keywords

Analgesia; Emergency medicine; Anesthesia, Regional

Outcome Measures

Primary Outcomes (1)

• Pain scores at rest

  45 minutes after the injection

Secondary Outcomes (4)

• 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

Study Arms (2)

Fascia iliaca block

EXPERIMENTAL

Fascia iliaca block (Injection of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®)

Procedure: Fascia iliaca block

Sham injection

SHAM COMPARATOR

No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention)

Procedure: Sham injection

Interventions

Fascia iliaca block PROCEDURE

injection of 30 mLs below the fascia iliaca

Fascia iliaca block

Sham injection PROCEDURE

subcutaneous of 5 cc of normal saline

Sham injection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patients with femoral neck fracture in the emergency department

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

CHUVaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures; Agnosia

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Albrecht, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr Eric Albrecht, MD, MER, DESA, Program Director, Regional Anaesthesia

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: May 5, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CH (1)