Contact information
Type
Scientific
Primary contact
Dr Barry Newman
ORCID ID
Contact details
Department of Anaesthesia
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
+44 (0)12 0244 2443
barry.newman@poole.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol version2 - 01/01/2011
Study information
Scientific title
Efficacy of Femoral Nerve Block vs Fascia Iliaca Block for preoperative analgesia in fracture neck of femur: a randomised unblinded comparison study
Acronym
FNB-v-FIB
Study hypothesis
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
Isle of Wight, Portsmouth & South East Hampshire Local Research Ethics Committee, 09/11/2011, ref: REC10/H0501/25
Study design
Randomised unblinded comparison study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Fracture of femur
Intervention
Femoral Nerve Block versus Femoral Iliaca Block
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
01/03/2011
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/03/2011
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Poole
BH15 2JB
United Kingdom
Sponsor information
Organisation
Poole Hospital NHS Foundation Trust (UK)
Sponsor details
Longfleet Road
Poole
BH15 2JB
United Kingdom
+44 (0)12 0244 8125
Mary.burrows@poole.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Poole Hospital NHS Foundation Trust (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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23789738
Publication citations
-
Results
Newman B, McCarthy L, Thomas PW, May P, Layzell M, Horn K, A comparison of pre-operative nerve stimulator-guided femoral nerve block and fascia iliaca compartment block in patients with a femoral neck fracture., Anaesthesia, 2013, 68, 9, 899-903, doi: 10.1111/anae.12321.