Back to resultsAnesthesia in PROstate Biopsy Pain Obstruction Study (APROPOS)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
perineal nerve block
periprostatic block
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, transperineal prostate biopsy, perineal nerve block, periprostatic block, anesthesia
Eligibility Criteria
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;
Sites / Locations
- Shanghai East Hospital, Tongji University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Perineal nerve block
Periprostatic block
Arm Description
Man receive the perineal nerve block before under the transperineal prostate biopsy
Man receive the periprostatic block before under the transperineal prostate biopsy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Changes in blood pressure during biopsy procedure
The changes will be measured and recorded by multi-parameter monitoring
Changes in heart rate during biopsy procedure
The changes will be measured and recorded by multi-parameter monitoring
Changes in breath rate during biopsy procedure
The changes will be measured and recorded by multi-parameter monitoring
The detection rate for prostate cancer
The detection rate for any of the prostate cancer
The detection rate for clinically significant prostate cancer
The detection rate for prostate cancer with a ISUP>2
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).
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).
Adverse event
Any of the adverse events during the trial
The number of biopsy cores
The number of biopsy cores
The location of each biopsy core
The location of each biopsy core
Prostate volume
The prostate volume will be measured by MRI before biopsy
Full Information
NCT ID
NCT04501055
First Posted
July 29, 2020
Last Updated
October 26, 2022
Sponsor
Shanghai East Hospital
Collaborators
Shi Shi Municipal General Hospital, People's Hospital of Yiyuan County, The First Affiliated Hospital of University of Science and Technology of China, Guang'an people's hospital of Sichuan province, Chinese University of Hong Kong, Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04501055
Brief Title
Anesthesia in PROstate Biopsy Pain Obstruction Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
Collaborators
Shi Shi Municipal General Hospital, People's Hospital of Yiyuan County, The First Affiliated Hospital of University of Science and Technology of China, Guang'an people's hospital of Sichuan province, Chinese University of Hong Kong, Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, transperineal prostate biopsy, perineal nerve block, periprostatic block, anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participant, the investigator and the outcomes assessor were all masked. Only the care provider who performed the anaesthesia were not blinded but they were not involved in the subsequent prostate biopsy, pain assessment, data collection and data analysis.
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perineal nerve block
Arm Type
Experimental
Arm Description
Man receive the perineal nerve block before under the transperineal prostate biopsy
Arm Title
Periprostatic block
Arm Type
Active Comparator
Arm Description
Man receive the periprostatic block before under the transperineal prostate biopsy
Intervention Type
Behavioral
Intervention Name(s)
perineal nerve block
Intervention Description
An anesthesia method to block perineal nerve
Intervention Type
Behavioral
Intervention Name(s)
periprostatic block
Intervention Description
An anesthesia method to block periprostate
Primary Outcome Measure Information:
Title
The pain of the biopsy procedure
Description
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 Outcome Measure Information:
Title
The pain in 1,6, and 12 hours after the biopsy
Description
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
Title
Changes in blood pressure during biopsy procedure
Description
The changes will be measured and recorded by multi-parameter monitoring
Time Frame
During the biopsy procedure
Title
Changes in heart rate during biopsy procedure
Description
The changes will be measured and recorded by multi-parameter monitoring
Time Frame
During the biopsy procedure
Title
Changes in breath rate during biopsy procedure
Description
The changes will be measured and recorded by multi-parameter monitoring
Time Frame
During the biopsy procedure
Title
The detection rate for prostate cancer
Description
The detection rate for any of the prostate cancer
Time Frame
within 1 month after the biopsy
Title
The detection rate for clinically significant prostate cancer
Description
The detection rate for prostate cancer with a ISUP>2
Time Frame
within 1 month after the biopsy
Title
External manifestation of pain
Description
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
Title
Anaesthesia satisfaction
Description
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
Title
Adverse event
Description
Any of the adverse events during the trial
Time Frame
Within 1 week after the biopsy
Title
The number of biopsy cores
Description
The number of biopsy cores
Time Frame
10 minutes within biopsy
Title
The location of each biopsy core
Description
The location of each biopsy core
Time Frame
10 minutes within biopsy
Title
Prostate volume
Description
The prostate volume will be measured by MRI before biopsy
Time Frame
within 3 months before the biopsy procedure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haifeng Wang
Organizational Affiliation
Shanghai East Hospital,Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital, Tongji University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34692757
Citation
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.
Results Reference
derived
Learn more about this trial
Anesthesia in PROstate Biopsy Pain Obstruction Study
We'll reach out to this number within 24 hrs