Anesthesia in PROstate Biopsy Pain Obstruction Study

Prostate Cancer Clinical Trial

— APROPOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501055
• Other study ID #: APROPOS-01
• Status: Completed
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: July 27, 2022

Study information

• Verified date: October 2022
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 27, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• perineal nerve block
An anesthesia method to block perineal nerve
• periprostatic block
An anesthesia method to block periprostate

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai East Hospital	Chinese University of Hong Kong, Chongqing Medical University, Guang'an people's hospital of Sichuan province, People's Hospital of Yiyuan County, Shi Shi Municipal General Hospital, The First Affiliated Hospital of University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

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