Anesthesia in PROstate Biopsy Pain Obstruction Study

Shanghai East Hospital192 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

192

Conditions

Prostate Cancer

Interventions

perineal nerve blockBEHAVIORAL

An anesthesia method to block perineal nerve

periprostatic blockBEHAVIORAL

An anesthesia method to block periprostate

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

The pain of the biopsy procedure

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.

Time frame: within10 minutes after the prostate biopsy

Secondary Outcomes

The pain in 1,6, and 12 hours after the biopsy

The pain in 1,6, and 12 hours 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.

Time frame: 1,6, and 12 hours after the biopsy

Changes in blood pressure during biopsy procedure

The changes will be measured and recorded by multi-parameter monitoring

Time frame: During the biopsy procedure

Changes in heart rate during biopsy procedure

The changes will be measured and recorded by multi-parameter monitoring

Time frame: During the biopsy procedure

Changes in breath rate during biopsy procedure

The changes will be measured and recorded by multi-parameter monitoring

Time frame: During the biopsy procedure

The detection rate for prostate cancer

The detection rate for any of the prostate cancer

Time frame: within 1 month after the biopsy

The detection rate for clinically significant prostate cancer

The detection rate for prostate cancer with a ISUP\>2

Time frame: within 1 month after the biopsy

Data from ClinicalTrials.gov

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External manifestation of pain

A questionnaire with five items: the degree of facial expression (0 for no particular expression or smile; 1 for an occasional grimace or frown, a withdrawn expression, or a disinterested expression; 2 for frequent or constant quivering chin or a clenched jaw), the degree of activity (0 for lying quietly or being in a normal position, 1 for slight contractions of the hip muscles or slight movements of hip, 2 for severe contractions of the hip or lifting the hip out of the bed), the degree of voice expression (0 for quiet or normal communication, 1 for an occasional moan or weeping sound, 2 for constant moaning or sobbing and screaming), the degree of pacification (0 for being peaceful and not requiring pacification, 1 for being able to be comforted easily, 2 for being difficult to comfort) and the degree of cooperation (0 for being calm and cooperative, 1 for language resistance, 2 for body resistance).

Time frame: 10 minutes within biopsy

Anaesthesia satisfaction

A questionnaire with five items :whether the pain during the biopsy was less severe than expected (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe than expected); whether the pain after anaesthesia was less severe than the pain during anaesthesia (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe); weather the patient is satisfied with the overall feeling of the biopsy (scores from 0 to 10, where 0 represents the highest level of satisfaction and 10 represents the lowest level of satisfaction); whether the patient would recommend this type of biopsy to other patients (scores from 0 to 10, where 0 represents they would highly recommend it and 10 represents they would definitely not recommend it); and whether the patient would still want to choose this way if they have to undergo another biopsy (scores from 0 to 10, where 0 represents very willing to choose it and 10 represents extreme reluctance).

Time frame: 24 hours after the biopsy