Combining surface and infiltration anaesthesia for Transrectal Ultrasonography of the Prostate (TRUS) biopsy: is it better?

ISRCTN	ISRCTN77665682
DOI	https://doi.org/10.1186/ISRCTN77665682
Protocol serial number	N0155153512
Sponsor	Department of Health
Funder	Pennine Acute Hospitals NHS Trust (UK), NHS R&D Support Funding Own Account

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

Mr R. Krishnan
Scientific

Urology Unit
Royal Oldham Hospital
Oldham
OL1 2PN
United Kingdom

Primary study design	Interventional
Study design	Double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Pain relief by visual analogue score
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	80
Key inclusion criteria	80 patients undergoing Transrectal Ultrasonography of the Prostate (TRUS) biopsy
Key exclusion criteria	Known allergy to lignocaine.
Date of first enrolment	07/07/2004
Date of final enrolment	30/09/2004

Urology Unit

Oldham
OL1 2PN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan