Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

July 15, 2023 updated by: zhuhao, RenJi Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine + sufentanil intervention group
Drug: lidocaine and sufentanil
A total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder through the catheter.
Placebo Comparator: Saline control group
Drug: Saline
A total of 20ml normal saline was injected into the bladder through the catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of CRBD
Time Frame: immediately after extubation in resuscitation
incidence of CRBD
immediately after extubation in resuscitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 7, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

July 15, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2023-0092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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