Condition category
Musculoskeletal Diseases
Date applied
04/07/2006
Date assigned
08/08/2006
Last edited
05/01/2012
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 John Carlisle

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SDHCT03/02/002; NRR Pub. ID: N0224122747

Study information

Scientific title

Acronym

FNB study

Study hypothesis

To determine whether local anaesthetic blockade of the femoral nerve reduces pain from fractured proximal femurs.

Ethics approval

South Devon Research Ethics Committee (formerly Torbay REC) approval gained on 14th February 2003 (reference number: 36/08/02).

Study design

Randomised, double blind, placebo controlled trial

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

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 names

Bupivacaine

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

20/02/2004

Overall trial end date

30/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Fractured proximal femur
3. Capable of informed consent
4. Written informed consent obtained

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

268

Participant 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

Recruitment start date

20/02/2004

Recruitment end date

30/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics Department
Torquay
TQ2 7AA
United Kingdom

Sponsor information

Organisation

South Devon Healthcare NHS Trust (UK)

Sponsor details

Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sdhct.nhs.uk/

Funders

Funder type

Charity

Funder name

Torbay Medical Research Fund

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

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18042893

Publication citations

  1. Results

    Schiferer A, Gore C, Gorove L, Lang T, Steinlechner B, Zimpfer M, Kober A, A randomized controlled trial of femoral nerve blockade administered preclinically for pain relief in femoral trauma., Anesth. Analg., 2007, 105, 6, 1852-4, table of contents, doi: 10.1213/01.ane.0000287676.39323.9e.

Additional files

Editorial Notes