Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
11/10/2011
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

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes