|
ISRCTN
|
ISRCTN57941461
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
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
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0360177161
|
|
Study hypothesis
|
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
|
Not provided at time of registration
|
|
Study design
|
Randomised prospective double blinded placebo controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Surgery: Foot and ankle
|
|
Participants - inclusion criteria
|
Patients undergoing ankle and hindfoot surgery.
|
|
Participants - exclusion criteria
|
1. Dementia
2. Peripheral neuropathy
|
|
Anticipated start date
|
01/06/2006
|
|
Anticipated end date
|
01/06/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
56
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Mean patient visual analogue pain scores over 72 hours post-operatively.
|
|
Secondary outcome measure(s)
|
1. Time to mobilise
2. Time to discharge
|
|
Sources of funding
|
North Hampshire Hospitals NHS Trust (UK)
NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
James
Calder
|
|
Address
|
North Hampshire Hospital NHS Trust
Aldermaston Road
|
|
City/town
|
Basingstoke
|
|
Zip/Postcode
|
RG24 9NA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01256 313156
|
|
Fax
|
+44 01256 313162
|
|
Email
|
j.calder@ic.ac.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
29/09/2006
|
|
Last edited
|
17/07/2008
|
|
Date ISRCTN assigned
|
29/09/2006
|
