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

NCT ID: NCT06301308

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-02-29

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intraurethral lidocaine gel alone

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

Group Type: SHAM_COMPARATOR

Intraurethral lidocaine gel alone

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Intraurethral lidocaine gel + lidocaine 2% injection

Intervention Type: 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.

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%

Group Type: EXPERIMENTAL

intraurethral lidocaine gel + liquid paraffinl

Intervention Type: DRUG

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

Interventions

Intraurethral lidocaine gel alone

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

Intervention Type: 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.

Intervention Type: 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%

Intervention Type: DRUG

Other Intervention Names

Group A; Group B; Group C

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.

• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Cheng Shunhua

Co-chief superintendent nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shunhua Cheng

Role: STUDY_CHAIR

Central South University,the second xiangya hospital

Can Tang

Role: STUDY_DIRECTOR

Central South University,the second xiangya hospital

Shunhua Cheng

Role: PRINCIPAL_INVESTIGATOR

Central South University,the second xiangya hospital

Locations

The second xiangya hospital

Changsha, Hunan, China

Countries

China

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2022021

Identifier Type: -

Identifier Source: org_study_id