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

NCT06301308 | Withdrawn Phase 3

• 1 other identifier: 2022021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative complications

  Within three days after surgery.

Study Arms (3)

Intraurethral lidocaine gel alone

SHAM COMPARATOR

Participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%

Drug: Intraurethral lidocaine gel alone

Intraurethral lidocaine gel + lidocaine 2% injection

EXPERIMENTAL

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

intraurethral lidocaine gel + liquid paraffinl

EXPERIMENTAL

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

Interventions

Intraurethral lidocaine gel alone DRUG

participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%

Also known as: Group A

Intraurethral lidocaine gel alone

Intraurethral lidocaine gel + lidocaine 2% injection DRUG

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.

Also known as: Group B

Intraurethral lidocaine gel + lidocaine 2% injection

intraurethral lidocaine gel + liquid paraffinl DRUG

Liquid paraffin were used to lubricate hte cystoscopy tube AND participants received 10 ml of intraurethral lidocaine gel at a concentration of 2%

Also known as: Group C

intraurethral lidocaine gel + liquid paraffinl

Eligibility Criteria

• Age: Up to 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 1. Other evident causes contributing to lower urinary tract symptoms, such as obvious glandular cystitis and severe urinary tract infections.
• \. Excessive prostatic hyperplasia. 3. Urethral stricture. 4. A history of prior urethral surgeries. 5. Uncontrolled hypertension, cardiac conditions, and chronic obstructive pulmonary disease.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The second xiangya hospital

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Lidocaine; Injections

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Shunhua Cheng

  Central South University,the second xiangya hospital

  STUDY CHAIR

• Can Tang

  Central South University,the second xiangya hospital

  STUDY DIRECTOR

• Shunhua Cheng

  Central South University,the second xiangya hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-chief superintendent nurse

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: October 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)