Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
21/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Philip Stott

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (PR)
Princess Royal
Lewes Road
Haywards Heath
RH16 4EX
United Kingdom
philstott@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0051166093

Study information

Scientific title

Acronym

Study hypothesis

Is a Patient Controlled Regional Anaesthesia (PCRA) technique better for patients undergoing forefoot reconstruction than the standard technique of nerve blocks and oral medication?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Surgery: Forefoot reconstruction

Intervention

Patients will be randomised into either the pain pump group or the standard technique group. All will receive a standardised general anaesthetic. Post operatively, visual analogue pain scores and patient satisfaction will be recorded. The patients will be discharged with the pump in situ.

Added 20/07/10: the trial never started.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Visual Analogue pain scores. Patient satisfaction levels.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2005

Overall trial end date

01/05/2006

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

30 patients undergoing forefoot reconstruction.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

1. Allergy to local anaesthetic
2. Any patient with previous surgery to that foot
3. Any patient requiring more extensive surgery e.g. Weil's osteonomies
4. Allergies/intolerances to NSAIDs

Recruitment start date

01/05/2005

Recruitment end date

01/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton & Sussex University Hospitals NHS Trust (PR)
Haywards Heath
RH16 4EX
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

Brighton and Sussex University Hospitals NHS Trust (UK) 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

Publication citations

Additional files

Editorial Notes