Contact information
Type
Scientific
Primary contact
Mr James Calder
ORCID ID
Contact details
North Hampshire Hospital NHS Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
+44 01256 313156
j.calder@ic.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0360177161
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Mean patient visual analogue pain scores over 72 hours post-operatively.
Secondary outcome measures
1. Time to mobilise
2. Time to discharge
Overall trial start date
01/06/2006
Overall trial end date
01/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing ankle and hindfoot surgery.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
56
Participant exclusion criteria
1. Dementia
2. Peripheral neuropathy
Recruitment start date
01/06/2006
Recruitment end date
01/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Hampshire Hospital NHS Trust
Basingstoke
RG24 9NA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Hampshire Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21189203
Publication citations
-
Results
Elliot R, Pearce CJ, Seifert C, Calder JD, Continuous infusion versus single bolus popliteal block following major ankle and hindfoot surgery: a prospective, randomized trial., Foot Ankle Int, 2010, 31, 12, 1043-1047, doi: 10.3113/FAI.2010.1043.