Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Benger

ORCID ID

Contact details

Bristol Royal Infirmary
Department of Emergency Medicine
Academic Department of Emergency Care
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7820

Study information

Scientific title

Randomised trial of the fascia-iliaca block versus the 'three-in-one' block for femoral neck fractures in the emergency department

Acronym

FIB trial

Study hypothesis

The FIB trial is a two group randomised equivalence trial investigating the effects of the fascia-iliaca block versus the "three-in-one" block on pain scores and analgesia requirement in the subsequent 24 hour period, in patients with radiologically confirmed fractured neck of femur presenting to the emergency department. The primary null hypothesis is that the fascia-iliaca block will be as effective as the "three-in-one" block in reducing pain and anlagesia requirement.

Ethics approval

Frenchay Ethics Committee approved on the 14th February 2008 (ref: 07/H0107/65)

Study design

Randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Injuries and Accidents; Subtopic: Injuries and Accidents (all Subtopics); Disease: Injuries & Accidents

Intervention

Intervention arm:
Fascia-iliaca block (FIB): At the point 1 cm beneath the junction of the outer and middle thirds of a line drawn between the superior anterior iliac crest and the pubic tubercle a 18G tuohy needle is inserted at 90 degrees until two distinct pops are felt as it penetrates the fascia lata and then fascia iliaca. The needle is aspirated to exclude intra-vascular placement and the sub-fascial compartment is then filled with 2 mg/kg (max 150 mg) of bupivicaine solution diluted to a volume of 30 ml if required.

Control arm:
3 in 1 Femoral Nerve Block: At the femoral crease immediately lateral to the femoral arterial pulse a stimuplex needle will be guided to within the femoral sheath using a nerve stimulator. When the needle is appropriately placed linear patellar movement will be seen at 30 mV but not less than 30 mV. At this time the needle will be aspirated to exclude intra-vascular placement and femoral sheath is injected with 2 mg/kg (max 150 mg) of bupivicaine solution diluted to a volume of 30 ml if required whilst occluding the femoral sheath to prevent distal LA spread.

Follow up period: 24 hours

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Pain as measured by the Visual Anologue Scale (VAS) score (0 = no pain, 10 = unbearable pain), at 0 minutes, 30 minutes and 60 minutes

Secondary outcome measures

1. Analgesia consumption: sum quantity of analgesia given within 24 hours of the block, measured at 24 hours post-nerve block
2. Hospital length of stay

Overall trial start date

01/12/2008

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with radiologically confirmed unilateral fractured neck of femur presenting to emergency department
2. Capacity to consent to participate in study
3. Aged greater than or equal to 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 190

Participant exclusion criteria

1. Patients unable to consent due to delirium, dementia or incapacity
2. Patients with other distracting painful pathology; patients with reduced level of consciousness
3. Patients who present greater than 24 hours post-injury
4. Patients for whom use of local anaesthesia agents is contraindicated
5. Patients who decline to take part in the study
6. Patients who are unable to speak or understand English

Recruitment start date

01/12/2008

Recruitment end date

01/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Bristol Royal Infirmary (UK)

Sponsor details

Gastroenterology Research Group
Research Floor Level 7
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhbristol.nhs.uk/your-hospitals/bristol-royal-infirmary.html

Funders

Funder type

University/education

Funder name

The College of Emergency Medicine (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25430915

Publication citations

Additional files

Editorial Notes

24/05/2016: Publication reference added.