Anesthesia in PROstate Biopsy Pain Obstruction Study (APROPOS)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: perineal nerve block; Behavioral: periprostatic block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital, Tongji University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Collaborators: Chinese University of Hong Kong; Chongqing Medical University; The First Affiliated Hospital of University of Science and Technology of China; Shi Shi Municipal General Hospital; People's Hospital of Yiyuan County; Guang'an people's hospital of Sichuan province
• Investigators: Principal Investigator: Haifeng Wang, Shanghai East Hospital,Tongji University School of Medicine

Publications and helpful links

General Publications

• He BM, Li RB, Wang HF. Anaesthesia in PROstate Biopsy Pain Obstruction Study: A Study Protocol for a Multicentre Randomised Controlled Study Evaluating the Efficacy of Perineal Nerve Block in Controlling Pain in Patients Undergoing Transperineal Prostate Biopsy. Front Surg. 2021 Oct 6;8:649822. doi: 10.3389/fsurg.2021.649822. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: anesthesia; Prostate Cancer; transperineal prostate biopsy; periprostatic block; perineal nerve block
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: APROPOS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee.
• IPD Sharing Time Frame: Data will become available after publication with no end date
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No