Clinical trial NCT06301308: A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
Official title: A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Bladder Cancer
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 0
Sex: MALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The primary objective of this clinical trial is to investigate the efficacy of a novel application of lidocaine injection in alleviating pain for male patients undergoing rigid cystoscopy procedures. Rigid cystoscopy is a common diagnostic examination used to visualize the interior of the bladder and urethra. However, it can be associated with discomfort and pain for patients.

The central question driving this study is whether the new application of lidocaine liquid can provide effective pain relief during cystoscopy. To address this question, participants will be randomly assigned to one of three anesthesia mode groups: Group A, which will receive intraurethral lidocaine gel alone; Group B, which will receive intraurethral lidocaine gel along with lidocaine 2% injection; and Group C, which will receive intraurethral lidocaine gel along with liquid paraffin.

Those assigned to Group B or Group C will only need to prepare and cooperate according to routine surgical operations. This standardizes the pre-procedural preparation process across the study groups, ensuring consistency in the approach to anesthesia administration.

By comparing the pain levels experienced by patients in each group during cystoscopy, the study aims to determine the effectiveness of the new lidocaine application method in providing pain relief. This information will be crucial in improving the patient experience during cystoscopy procedures and potentially optimizing anesthesia protocols for future clinical practice.

Eligibility criteria: Inclusion Criteria:

* Male patients under the age of 50 referred for postoperative cystoscopy for bladder cancer

Exclusion Criteria:

- 1. Other evident causes contributing to lower urinary tract symptoms, such as obvious glandular cystitis and severe urinary tract infections.

2. Excessive prostatic hyperplasia. 3. Urethral stricture. 4. A history of prior urethral surgeries. 5. Uncontrolled hypertension, cardiac conditions, and chronic obstructive pulmonary disease.

Primary outcomes:
measure: Access the pain score using the Visual Analogue Scale (VAS)
timeFrame: The procedure was evaluated using the visual analogue scale immediately afterward (referred to as "during the procedure" for the study's purposes) and again five minutes later.
Secondary outcomes:
measure: Postoperative complications
timeFrame: Within three days after surgery.
Other outcomes:
Locations:
city: Changsha
country: China
facility: The second xiangya hospital
state: Hunan
Study officials:
affiliation: Central South University,the second xiangya hospital
name: Shunhua Cheng
role: STUDY_CHAIR
affiliation: Central South University,the second xiangya hospital
name: Can Tang
role: STUDY_DIRECTOR
affiliation: Central South University,the second xiangya hospital
name: Shunhua Cheng
role: PRINCIPAL_INVESTIGATOR
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