Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/04/2014
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 R. Krishnan

ORCID ID

Contact details

Urology Unit
Royal Oldham Hospital
Oldham
OL1 2PN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0155153512

Study information

Scientific title

Acronym

Study hypothesis

Is combining surface and infiltration anaesthesia for Transrectal Ultrasonography of the Prostate (TRUS) biopsy more effective in relieving the pain of the procedure?

Ethics approval

Not provided at time of registration

Study design

Double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

The intervention is infiltration of local anaesthesia in periprostatic tissue with 1% lignocaine solution: and the ano-rectal mucosa anaesthetized by application of 2% lignocaine jelly.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Pain relief by visual analogue score

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/07/2004

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

80 patients undergoing Transrectal Ultrasonography of the Prostate (TRUS) biopsy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Known allergy to lignocaine.

Recruitment start date

07/07/2004

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Urology Unit
Oldham
OL1 2PN
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

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

Funders

Funder type

Government

Funder name

Pennine Acute Hospitals NHS Trust (UK), NHS R&D Support Funding Own Account

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