FIB trial: Fascia-iliaca block versus 'three-in-one' block for femoral neck fractures
| ISRCTN | ISRCTN16152419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16152419 |
| Secondary identifying numbers | 7820 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 24/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jonathan Benger
Scientific
Scientific
Bristol Royal Infirmary
Department of Emergency Medicine
Academic Department of Emergency Care
Bristol
BS2 8HW
United Kingdom
Study information
| Study design | Randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised trial of the fascia-iliaca block versus the 'three-in-one' block for femoral neck fractures in the emergency department |
| Study acronym | FIB trial |
| Study objectives | 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(s) | Frenchay Ethics Committee approved on the 14th February 2008 (ref: 07/H0107/65) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2008 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 190 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
Bristol Royal Infirmary (UK)
Hospital/treatment centre
Hospital/treatment centre
Gastroenterology Research Group, Research Floor Level 7
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
England
United Kingdom
| Website | http://www.uhbristol.nhs.uk/your-hospitals/bristol-royal-infirmary.html |
|---|---|
"ROR" |
https://ror.org/031p4kj21 |
Funders
Funder type
University/education
The College of Emergency Medicine (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2015 | Yes | No |
Editorial Notes
24/05/2016: Publication reference added.
