A Prospective Multicenter Randomized Controlled Trial Assessing Whether the Perineal Nerve Block Approach is Better Than the Periprostatic Block for the Pain Control in Men Who Undergo Transperineal Prostate Biopsy

Shanghai East Hospital1 site in 1 country192 target enrollmentAugust 13, 2020

ConditionsProstate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Shanghai East Hospital
Enrollment: 192
Locations: 1
Primary Endpoint: The pain of the biopsy procedure
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicentre randomized controlled trial in comparison of the perineal nerve block approach between the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

Detailed Description

This trial is a prospective, multicentre, randomized controlled study in which all men plan to undergo a transperineal prostate biopsy. This study aims to determine whether the perineal nerve block approach is better than the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

Registry

clinicaltrials.gov

Start Date

August 13, 2020

End Date

July 27, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Shanghai East Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•age between 18 and 80 years old
•a PSA level of 4 - 20 ng/ml, and/or suspicious rectal examination findings;
•fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria

•local anesthetic allergy patients;
•symptomatic acute or chronic inflammation of the prostate;
•cannot tolerate prostate biopsy or has contraindication to biopsy;
•patients judged by the investigator to be unsuitable to participate in the clinical trial;

Outcomes

Primary Outcomes

The pain of the biopsy procedure

Time Frame: within10 minutes after the prostate biopsy

The pain will be measured by numerical rating scale（NRS), which distributed from 0 to 10. 0 represents no pain, and 10 represents the worst pain imaginable.

Secondary Outcomes

The detection rate for prostate cancer(within 1 month after the biopsy)
The pain in 1,6, and 12 hours after the biopsy(1,6, and 12 hours after the biopsy)
Changes in blood pressure during biopsy procedure(During the biopsy procedure)
Changes in heart rate during biopsy procedure(During the biopsy procedure)
Changes in breath rate during biopsy procedure(During the biopsy procedure)
Adverse event(Within 1 week after the biopsy)
The detection rate for clinically significant prostate cancer(within 1 month after the biopsy)
External manifestation of pain(10 minutes within biopsy)
Anaesthesia satisfaction(24 hours after the biopsy)
The number of biopsy cores(10 minutes within biopsy)
The location of each biopsy core(10 minutes within biopsy)
Prostate volume(within 3 months before the biopsy procedure)