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 |
| Protocol serial number | N0077120719 |
| Sponsor | Department of Health (UK) |
| Funder | Southern Derbyshire Acute Hospitals NHS Trust (NHS R&D Support Funding) + charitable funds |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The use of intravesical lignocaine to reduce pain and increase dwell time of intravesical mitomycin chemotherapy |
| Study objectives | Does intravesical lignocaine reduce the pain and maximise the dwell time of intravesical mitomycin? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Mitomycin, lignocaine |
| Primary outcome measure(s) |
Visual analogue pain scores. Dwell time. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with transitional cell carcinoma of the bladder, following their first endoscopic resection. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 10/03/2003 |
| Date of final enrolment | 10/11/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
07/12/2015: no publications found on PubMed.
