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
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 |
|---|---|
| simon_wi@hotmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The use of intravesical lignocaine to reduce pain and increase dwell time of intravesical mitomycin chemotherapy |
| Study hypothesis | Does intravesical lignocaine reduce the pain and maximise the dwell time of intravesical mitomycin? |
| Ethics approval(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mitomycin, lignocaine |
| Primary outcome measure | Visual analogue pain scores. Dwell time. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/03/2003 |
| Overall study end date | 10/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | Patients with transitional cell carcinoma of the bladder, following their first endoscopic resection. |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 10/03/2003 |
| Recruitment end date | 10/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Department of Health (UK)
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
