A Randomised, Prospective, Double Blinded, Placebo Controlled Trial to Determine the Efficacy of Continuous Infusion Ankle Block Compared to Standard Single Bolus Block in the Management of Postoperative Pain Following Foot and Ankle Surgery

ISRCTN	ISRCTN57941461
DOI	https://doi.org/10.1186/ISRCTN57941461
Secondary identifying numbers	N0360177161

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr James Calder
Scientific

North Hampshire Hospital NHS Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Phone	+44 01256 313156
Email	j.calder@ic.ac.uk

Study design	Randomised prospective double blinded placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To assess the effectiveness of a single administration (bolus) of local anaesthetic to the nerves that supply the foot and ankle versus a bolus and continuous infusion of local anaesthetic to the same nerves in order to manage post operative pain following foot and ankle surgery.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Foot and ankle
Intervention	Continuous infusion ankle block vs standard single bolus block. Intention to treat analysis will be used. The outcomes of the two treatment groups will be evaluated using two-sample t tests, with 95% confidence intervals reported for the difference in means. Secondary binary outcomes will also be analysed using two sample t tests, but using a significance level of 1%. All analyses will be adjusted (using linear regression) for confounding variables that may differ by chance between the treatment groups. Stata for Windows (StataCorp, USA) will be the statistical package of choice.
Intervention type	Procedure/Surgery
Primary outcome measure	Mean patient visual analogue pain scores over 72 hours post-operatively.
Secondary outcome measures	1. Time to mobilise 2. Time to discharge
Overall study start date	01/06/2006
Completion date	01/06/2007

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	56
Key inclusion criteria	Patients undergoing ankle and hindfoot surgery.
Key exclusion criteria	1. Dementia 2. Peripheral neuropathy
Date of first enrolment	01/06/2006
Date of final enrolment	01/06/2007

North Hampshire Hospital NHS Trust

Basingstoke
RG24 9NA
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

North Hampshire Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

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	01/12/2010		Yes	No