Anesthesia in PROstate Biopsy Pain Obstruction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-13

Study Completion Date

2022-07-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The participant, the investigator and the outcomes assessor were all masked. Only the care provider who performed the anaesthesia were not blinded but they were not involved in the subsequent prostate biopsy, pain assessment, data collection and data analysis.

Study Groups

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Perineal nerve block

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

Group Type EXPERIMENTAL

perineal nerve block

Intervention Type BEHAVIORAL

An anesthesia method to block perineal nerve

Periprostatic block

Man receive the periprostatic block before under the transperineal prostate biopsy

Group Type ACTIVE_COMPARATOR

periprostatic block

Intervention Type BEHAVIORAL

An anesthesia method to block periprostate

Interventions

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periprostatic block

An anesthesia method to block periprostate

Intervention Type BEHAVIORAL

perineal nerve block

An anesthesia method to block perineal nerve

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes