Anesthesia in PROstate Biopsy Pain Obstruction Study (APROPOS)

October 26, 2022 updated by: Shanghai East Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The pain of the biopsy procedure
Time Frame: within10 minutes after the prostate biopsy
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The pain in 1,6, and 12 hours after the biopsy
Time Frame: 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
Time Frame: During the biopsy procedure
The changes will be measured and recorded by multi-parameter monitoring
During the biopsy procedure
Changes in heart rate during biopsy procedure
Time Frame: During the biopsy procedure
The changes will be measured and recorded by multi-parameter monitoring
During the biopsy procedure
Changes in breath rate during biopsy procedure
Time Frame: During the biopsy procedure
The changes will be measured and recorded by multi-parameter monitoring
During the biopsy procedure
The detection rate for prostate cancer
Time Frame: within 1 month after the biopsy
The detection rate for any of the prostate cancer
within 1 month after the biopsy
The detection rate for clinically significant prostate cancer
Time Frame: within 1 month after the biopsy
The detection rate for prostate cancer with a ISUP>2
within 1 month after the biopsy
External manifestation of pain
Time Frame: 10 minutes within biopsy
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
Time Frame: 24 hours after the biopsy
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
Time Frame: Within 1 week after the biopsy
Any of the adverse events during the trial
Within 1 week after the biopsy
The number of biopsy cores
Time Frame: 10 minutes within biopsy
The number of biopsy cores
10 minutes within biopsy
The location of each biopsy core
Time Frame: 10 minutes within biopsy
The location of each biopsy core
10 minutes within biopsy
Prostate volume
Time Frame: within 3 months before the biopsy procedure
The prostate volume will be measured by MRI before biopsy
within 3 months before the biopsy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai East Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haifeng Wang, Shanghai East Hospital,Tongji University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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