Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/12/2015
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 S Williams

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Surgery & Urology Department
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131 ext. 5538
simon_wi@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077120719

Study information

Scientific title

The use of intravesical lignocaine to reduce pain and increase dwell time of intravesical mitomycin chemotherapy

Acronym

Study hypothesis

Does intravesical lignocaine reduce the pain and maximise the dwell time of intravesical mitomycin?

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Analgesia for intravesical mitomycin chemotheapy

Intervention

30 min before mitomycin is instilled into the patients bladder, 40 ml 0.5% lignocaine or 40 ml saline (placebo) will be instilled. The catheter will then be clamped. After 30 min, the lignocaine/placebo will be drained and mitomycin instilled. Visual analogue scores of pain will be taken at 30, 60 and 120 min (or at first void if sooner). The time that the mitomycin is tolerated will be noted.

Intervention type

Drug

Phase

Not Applicable

Drug names

Mitomycin, lignocaine

Primary outcome measures

Visual analogue pain scores. Dwell time.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/03/2003

Overall trial end date

10/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with transitional cell carcinoma of the bladder, following their first endoscopic resection.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

10/03/2003

Recruitment end date

10/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Charity

Funder name

Southern Derbyshire Acute Hospitals NHS Trust (NHS R&D Support Funding) + charitable funds

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

07/12/2015: no publications found on PubMed.