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
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