Anesthesia in PROstate Biopsy Pain Obstruction Study

Study Overview
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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.

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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: perineal nerve block
* Behavioral: periprostatic block


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perineal nerve block<br>Man receive the perineal nerve block before under the transperineal prostate biopsy | Behavioral: perineal nerve block<br>* An anesthesia method to block perineal nerve<br>|
| Active Comparator: Periprostatic block<br>Man receive the periprostatic block before under the transperineal prostate biopsy | Behavioral: periprostatic block<br>* An anesthesia method to block periprostate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within10 minutes after the prostate biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | During the biopsy procedure | 
| Changes in heart rate during biopsy procedure | The changes will be measured and recorded by multi-parameter monitoring | During the biopsy procedure | 
| Changes in breath rate during biopsy procedure | The changes will be measured and recorded by multi-parameter monitoring | During the biopsy procedure | 
| The detection rate for prostate cancer | The detection rate for any of the prostate cancer | within 1 month after the biopsy | 
| The detection rate for clinically significant prostate cancer | The detection rate for prostate cancer with a ISUP>2 | within 1 month after the biopsy | 
| 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). | 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). | 24 hours after the biopsy | 
| Adverse event | Any of the adverse events during the trial | Within 1 week after the biopsy | 
| The number of biopsy cores | The number of biopsy cores | 10 minutes within biopsy | 
| The location of each biopsy core | The location of each biopsy core | 10 minutes within biopsy | 
| Prostate volume | The prostate volume will be measured by MRI before biopsy | within 3 months before the biopsy procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, transperineal prostate biopsy, perineal nerve block, periprostatic block, anesthesia