Contact information
Type
Scientific
Primary contact
Dr A S Lowe
ORCID ID
Contact details
Radiology
Lincoln Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436146667
Study information
Scientific title
Does the use of local anaesthetic make trans-rectal ultrasound guided biopsy more comfortable. To evaluate the pain experienced by the patient when having this procedure
Acronym
Study hypothesis
To assess whether the use of local anaesthetic makes trans-rectal ultrasound guided biopsy more comfortable. To evaluate the pain experienced by the patient when having this procedure.
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
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Surgery: Anaesthesia
Intervention
Randomised controlled trial
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
01/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Male patients referred for trans-rectal ultrasound guided biopsy as an outpatient to St James's
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
50
Participant exclusion criteria
1. Patients who are unable to answer the questionnaire (at the discretion of the radiographer, eg dementia, mental illness, language difficulties)
2. Patients not suitable for trans-rectal ultrasound biopsy
Recruitment start date
01/08/2002
Recruitment end date
01/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's University Hospital, Radiology
Lincoln Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
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
Leeds Teaching Hospitals NHS Trust (UK)
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