Efficacy of Femoral Nerve Block vs Fascia Iliaca Block for preoperative analgesia in fracture neck of femur

ISRCTN	ISRCTN81000264
DOI	https://doi.org/10.1186/ISRCTN81000264
Secondary identifying numbers	Protocol version2 - 01/01/2011

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Barry Newman
Scientific

Department of Anaesthesia
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom

Phone	+44 (0)12 0244 2443
Email	barry.newman@poole.nhs.uk

Study design	Randomised unblinded comparison study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Efficacy of Femoral Nerve Block vs Fascia Iliaca Block for preoperative analgesia in fracture neck of femur: a randomised unblinded comparison study
Study acronym	FNB-v-FIB
Study objectives	To determine whether one of the two standard techniques of local anaesthetic block of the femoral nerve is superior in terms of analgesia provided for elderly patients with fractured hip.
Ethics approval(s)	Isle of Wight, Portsmouth & South East Hampshire Local Research Ethics Committee, 09/11/2011, ref: REC10/H0501/25
Health condition(s) or problem(s) studied	Fracture of femur
Intervention	Femoral Nerve Block versus Femoral Iliaca Block
Intervention type	Other
Primary outcome measure	Differences in pain scores using the Linear Analogue Pain score immediately before and 2 hours after performing the block
Secondary outcome measures	Statistical difference between the consumption of analgesics in the 12 hours after the block
Overall study start date	01/03/2011
Completion date	31/12/2011

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	120
Key inclusion criteria	1. Patients male or female, admitted with diagnosis of fracture neck of femur 2. Patients with capability to give informed consent with Mini Mental Score Examination (MMSE) ≥ 8/10. MMSE is routinely performed on initial assessment of these patients.
Key exclusion criteria	1. Respiratory rate less than 10 beats per minute (bpm) 2. Systolic Blood Pressure less than 100 mm Hg 3. Glasgow Coma Scale (GCS) less than 12/15 4. Anticoagulant therapy (warfarin / heparin infusion). Not contraindicated in patients taking low dose aspirin < 150mg/day 5. Clotting disorders [international normalised ratio (INR) or activated partial thromboplastin time ratio (APTR)] > 1.5, Platelets < 80,000 6. Previous femoral vascular surgery 7. Hepatic Impairment 8. Debilitated or acutely ill patients 9. Patient refusal 10. Known hypersensitivity to local anaesthetic agents of amide type 11. MMSE < 8/10. Standard exclusion criteria for the local anaesthetic nerve block as per local protocol
Date of first enrolment	01/03/2011
Date of final enrolment	31/12/2011

Department of Anaesthesia

Poole
BH15 2JB
United Kingdom

Poole Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Longfleet Road
Poole
BH15 2JB
England
United Kingdom

Government

Poole Hospital NHS Foundation Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No