Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301308
Status:
WITHDRAWN
Last Update Posted:
2024-04-24
First Post:
2024-03-03
Brief Title:
A Novel Application of 2 Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
Sponsor:
Second Xiangya Hospital of Central South University
Organization:
Second Xiangya Hospital of Central South University
Study Overview
Official Title:
A Novel Application of 2 Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The standard measures of anaesthesia in cystoscopy are not uniform internationally and given this we were unable to recruit the first participant in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 isDoes New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy Before the cycstoscopyParticipants will be randomly divided into three different anesthesia mode groupsnamely are Group A intraurethral lidocaine gel alone Group B intraurethral lidocaine gel lidocaine 2 injection and Group C intraurethral lidocaine gel liquid paraffinlPatients only need to prepare and cooperate according to routine surgical operationswhich 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None