Condition category
Injury, Occupational Diseases, Poisoning
Date applied
22/02/2011
Date assigned
12/10/2011
Last edited
15/10/2014
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

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 measures

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23789738

Publication citations

  1. 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.

Additional files

Editorial Notes