Randomised controlled trial of Femoral Nerve Blockade for fractured femurs

ISRCTN	ISRCTN48754612
DOI	https://doi.org/10.1186/ISRCTN48754612
Protocol serial number	SDHCT03/02/002; NRR Pub. ID: N0224122747
Sponsor	South Devon Healthcare NHS Trust (UK)
Funder	Torbay Medical Research Fund

Submission date: 04/07/2006
Registration date: 08/08/2006
Last edited: 05/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Carlisle
Scientific

Anaesthetics Department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised, double blind, placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	FNB study
Study objectives	To determine whether local anaesthetic blockade of the femoral nerve reduces pain from fractured proximal femurs.
Ethics approval(s)	South Devon Research Ethics Committee (formerly Torbay REC) approval gained on 14th February 2003 (reference number: 36/08/02).
Health condition(s) or problem(s) studied	Fractured proximal femurs
Intervention	Local anaesthetic blockade of the femoral nerve (0.5% bupivacaine) versus placebo (0.9% sterile saline) in patients with fractured proximal femurs.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bupivacaine
Primary outcome measure(s)	To assess the quality of anaesthesia provided by systemic opioids alone or combined with femoral nerve blockade in two otherwise equivalent groups by measuring pain scores and levels of systemic opioid administration required.
Key secondary outcome measure(s)	1. To assess mental function using a standard ten point scale (Abbreviated Mental Test Score [AMTS]) and a 30 point scale (Mini Mental State Examination [MMSE]) before and after the operation, comparing the two groups 2. To assess mobility and function, using a modified Physiotherapy Functional Mobility Profile (PFMP) and achievement of activities for daily living score (MIMS), before and after the operation, comparing the two groups 3. To monitor the lengths of stay in the two groups 4. To monitor the incidence of death in the two groups at 30 days and 90 days 5. To monitor the levels and incidence of infections to the wound, prosthesis and/or catheter post operatively
Completion date	30/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	268
Key inclusion criteria	1. Aged over 18 years 2. Fractured proximal femur 3. Capable of informed consent 4. Written informed consent obtained
Key exclusion criteria	1. Documented allergy to bupivacaine 2. Infection at the site of catheter placement 3. Aged under 18 years 4. Unable to give informed consent 5. Refusal to give informed consent
Date of first enrolment	20/02/2004
Date of final enrolment	30/10/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Anaesthetics Department

Torquay
TQ2 7AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/12/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes