A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial

Phase 3

Withdrawn

• Conditions: Bladder Cancer
• Interventions: Drug: Intraurethral lidocaine gel alone; Drug: Intraurethral lidocaine gel + lidocaine 2% injection; Drug: intraurethral lidocaine gel + liquid paraffinl

• Registration Number: NCT06301308
• Lead Sponsor: Second Xiangya Hospital of Central South University

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.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-03-03
• Study First Posted: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intraurethral lidocaine gel alone	Intraurethral lidocaine gel alone	Participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%
Intraurethral lidocaine gel + lidocaine 2% injection	Intraurethral lidocaine gel + lidocaine 2% injection	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 paraffinl	intraurethral lidocaine gel + liquid paraffinl	Liquid paraffin were used to lubricate hte cystoscopy tube AND participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%

Primary Outcome Measures

Name	Time	Method
Access the pain score using the Visual Analogue Scale (VAS)	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.	Access the pain score assessed using the Visual Analogue Scale (VAS) during the procedure

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Within three days after surgery.	The second outcomes were included parameters such as field of view occlusion, duration of pain, hematuria duration, and lower urinary tract symptoms post-procedure.

Trial Locations

Locations (1)

The second xiangya hospital; 🇨🇳 Changsha, Hunan, China