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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: Intraurethral lidocaine gel alone; Drug: Intraurethral lidocaine gel + lidocaine 2% injection; Drug: intraurethral lidocaine gel + liquid paraffinl

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • The second xiangya hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Intraurethral lidocaine gel alone; Participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%	Drug: Intraurethral lidocaine gel alone; participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%; Other Names: Group A
Experimental: 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.	Drug: 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.; Other Names: Group B
Experimental: 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%	Drug: 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%; Other Names: Group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access the pain score using the Visual Analogue Scale (VAS)	Access the pain score assessed using the Visual Analogue Scale (VAS) during the procedure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Investigators: Study Chair: Shunhua Cheng, Central South University,the second xiangya hospital; Study Director: Can Tang, Central South University,the second xiangya hospital; Principal Investigator: Shunhua Cheng, Central South University,the second xiangya hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2022021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No