Back to resultsFascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
Primary Purpose
Femoral Neck Fracture
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Fascia iliaca block
Sham injection
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring Analgesia, Emergency medicine, Anesthesia, Regional
Eligibility Criteria
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
Sites / Locations
- CHUVaudois
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Fascia iliaca block
Sham injection
Arm Description
Fascia iliaca block (Injection of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®)
No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention)
Outcomes
Primary Outcome Measures
Pain scores at rest
Secondary Outcome Measures
Pain scores at rest
Pain scores on movement
Morphine consumption
Length of stay
Full Information
NCT ID
NCT02433548
First Posted
October 20, 2014
Last Updated
September 26, 2016
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT02433548
Brief Title
Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
Official Title
Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
Analgesia, Emergency medicine, Anesthesia, Regional
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fascia iliaca block
Arm Type
Experimental
Arm Description
Fascia iliaca block (Injection of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®)
Arm Title
Sham injection
Arm Type
Sham Comparator
Arm Description
No fascia iliaca block (Sham injection = Subcutaneous injection of 5 cc of normal saline, no intervention)
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca block
Intervention Description
injection of 30 mLs below the fascia iliaca
Intervention Type
Procedure
Intervention Name(s)
Sham injection
Intervention Description
subcutaneous of 5 cc of normal saline
Primary Outcome Measure Information:
Title
Pain scores at rest
Time Frame
45 minutes after the injection
Secondary Outcome Measure Information:
Title
Pain scores at rest
Time Frame
60 min, 4h, 8h, 12h, 24h after the injection
Title
Pain scores on movement
Time Frame
60 min, 4h, 8h, 12h, 24h after the injection
Title
Morphine consumption
Time Frame
60 min, 4h, 8h, 12h, 24h after the injection
Title
Length of stay
Time Frame
up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUVaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
33238043
Citation
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.
Results Reference
derived
PubMed Identifier
31262265
Citation
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.
Results Reference
derived
Learn more about this trial
Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
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