Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

Phase 4

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: lidocaine and sufentanil; Drug: Saline

• Registration Number: NCT05957653
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-15
• Study First Submitted QC: 2023-07-15
• Last Update Submitted: 2023-07-15
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24
• Study Start: 2023-10-07
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine + sufentanil intervention group	lidocaine and sufentanil	-
Saline control group	Saline	-

Primary Outcome Measures

Name	Time	Method
incidence of CRBD	immediately after extubation in resuscitation	incidence of CRBD