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

ISRCTN ISRCTN65454120
DOI https://doi.org/10.1186/ISRCTN65454120
Secondary identifying numbers N0077120719
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
13/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Mr S Williams
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
Surgery & Urology Department
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Phone +44 (0)1332 340131 ext. 5538
Email simon_wi@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe use of intravesical lignocaine to reduce pain and increase dwell time of intravesical mitomycin chemotherapy
Study hypothesisDoes intravesical lignocaine reduce the pain and maximise the dwell time of intravesical mitomycin?
Ethics approval(s)Not provided at time of registration
ConditionAnalgesia for intravesical mitomycin chemotheapy
Intervention30 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Mitomycin, lignocaine
Primary outcome measureVisual analogue pain scores. Dwell time.
Secondary outcome measuresNot provided at time of registration
Overall study start date10/03/2003
Overall study end date10/11/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Participant inclusion criteriaPatients with transitional cell carcinoma of the bladder, following their first endoscopic resection.
Participant exclusion criteriaDoes not meet inclusion criteria
Recruitment start date10/03/2003
Recruitment end date10/11/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
07/12/2015: no publications found on PubMed.