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

ISRCTN ISRCTN63597270
DOI https://doi.org/10.1186/ISRCTN63597270
Protocol serial number N0436146667
Sponsor Department of Health
Funder Leeds Teaching Hospitals NHS Trust (UK)
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
27/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A S Lowe
Scientific

Radiology
Lincoln Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone +44 (0)113 243 3144
Email r&d@leedsth.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleDoes 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
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Anaesthesia
InterventionRandomised controlled trial
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/06/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target sample size at registration50
Key inclusion criteriaMale patients referred for trans-rectal ultrasound guided biopsy as an outpatient to St James's
Key exclusion criteria1. 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
Date of first enrolment01/08/2002
Date of final enrolment01/06/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

St James's University Hospital, Radiology
Lincoln Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

27/04/2018: No publications found, verifying study status with principal investigator.
18/03/2016: No publications found, verifying study status with principal investigator.