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Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Not yet enrolling
Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Saline
Drug: lidocaine and sufentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT05957653
IIT-2023-0092

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

Male

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

140 participants in 2 patient groups, including a placebo group

Lidocaine + sufentanil intervention group
Experimental group
Treatment:
Drug: lidocaine and sufentanil
Saline control group
Placebo Comparator group
Treatment:
Drug: Saline

Trial contacts and locations

0

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Central trial contact

Hao Zhu

Data sourced from clinicaltrials.gov

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