Anesthesia in PROstate Biopsy Pain Obstruction Study (APROPOS)

Tongji University

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: periprostatic block; Behavioral: perineal nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT04501055

APROPOS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 2 patient groups

Perineal nerve block

Experimental group

Description:

Man receive the perineal nerve block before under the transperineal prostate biopsy

Treatment:

Behavioral: perineal nerve block

Periprostatic block

Active Comparator group

Description:

Man receive the periprostatic block before under the transperineal prostate biopsy

Treatment:

Behavioral: periprostatic block