Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

Prostate Cancer Clinical Trial

Official title:

Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05957653
• Other study ID #: IIT-2023-0092
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 7, 2023
• Est. completion date: October 30, 2025

Study information

• Verified date: July 2023
• Source: RenJi Hospital
• Contact: Hao Zhu
• Phone: 008602168383702
• Email: zhuhaossmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy.

The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation.

A total of 20ml of 2% lidocaine and 1μg/ml sufentanil or 20ml normal saline was injected into the bladder of the participants through the catheter. After drug injection, the catheter was clamped for 20 minutes, and then 100ml normal saline was injected into the bladder through the catheter to flush out.

Then, the incidence of CRBD was compared between the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: October 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. aged 18-79 years, ASA class I-II

2. participants undergoing robot-assisted radical prostatectomy under general anesthesia

3. signed informed consent and volunteered to participate in the experiment

Exclusion Criteria:

1. urethral stricture, difficulty in inserting catheter or urethral bleeding during catheterization

2. a preexisting bladder disease such as an overactive bladder, bladder outflow obstruction, and neurogenic bladder

3. cognitive impairment or communication disorders

4. severe heart, lung, liver, kidney and immune system diseases

5. confirmed or suspected allergy to this trial drug

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• lidocaine and sufentanil
A total of 20ml of 2% lidocaine and 1µg/ml sufentanil was injected into the bladder through the catheter.
• Saline
A total of 20ml normal saline was injected into the bladder through the catheter.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of CRBD	incidence of CRBD	immediately after extubation in resuscitation