| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN57941461 |
| Date ISRCTN assigned | 29/09/2006 |
| Local reference number(s) | N0360177161 |
| 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 |
| Disease/condition/study domain | Surgery: Foot and ankle |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information provided as of 29 September 2006 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients undergoing ankle and hindfoot surgery. |
| Participants - exclusion criteria | 1. Dementia
2. Peripheral neuropathy |
| Patient information material |
|
| Anticipated start date | 01/06/2006 |
| Anticipated end date | 01/06/2007 |
| Status of trial | Completed |
| Target number of participants | 56 |
| Interventions | 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
North Hampshire Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr James Calder |
| Contact details | North Hampshire Hospital NHS Trust
Aldermaston Road
Basingstoke
United Kingdom
RG24 9NA |
| Contact telephone | +44 01256 313156 |
| Contact fax | +44 01256 313162 |
| Contact email | j.calder@ic.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN57941461 |
| Date last extracted from ISRCTN register | 17/04/2008 |
