A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
Key facts
- Who runs it
- Second Xiangya Hospital of Central South University
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 3
- Started
- 1 Oct 2023
- Ended
- 29 Feb 2024
- Type of study
- Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Intraurethral lidocaine gel alone
- Intraurethral lidocaine gel + lidocaine 2% injection
- intraurethral lidocaine gel + liquid paraffinl
- Record updated
- 24 April 2024
- Why it stopped
- The standard measures of anaesthesia in cystoscopy are not uniform internationally, and given this, we were unable to recruit the first participant in the study.
Who can take part
- Age
- Up to 50 years
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- Male patients under the age of 50 referred for postoperative cystoscopy for bladder cancer
Who cannot take part
- Excessive prostatic hyperplasia. 3. Urethral stricture. 4. A history of prior urethral surgeries. 5. Uncontrolled hypertension, cardiac conditions, and chronic obstructive pulmonary disease
- 1. Other evident causes contributing to lower urinary tract symptoms, such as obvious glandular cystitis and severe urinary tract infections
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C.
The 3 groups in the trial
- Intraurethral lidocaine gel aloneSham treatment, for comparison
Participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%
- Intraurethral lidocaine gel + lidocaine 2% injectionTreatment being tested
Participants received 10 ml of intraurethral lidocaine gel at a concentration of 2% and using the injection of lidocaine 2% to irrigate the urethra using a 20 ml syringe.
- intraurethral lidocaine gel + liquid paraffinlTreatment being tested
Liquid paraffin were used to lubricate hte cystoscopy tube AND participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 24 April 2024