Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shi Shi Municipal General Hospital | UNKNOWN |
| People's Hospital of Yiyuan County | UNKNOWN |
| The First Affiliated Hospital of University of Science and Technology of China | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineal nerve block | Experimental | Man receive the perineal nerve block before under the transperineal prostate biopsy |
|
| Periprostatic block | Active Comparator | Man receive the periprostatic block before under the transperineal prostate biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perineal nerve block | Behavioral | An anesthesia method to block perineal nerve |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Haifeng Wang | Shanghai East Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | Shanghai | Shanghai Municipality | 200120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37007736 | Derived | He BM, Ka-Fung Chiu P, Tao T, Lan JH, Cai JT, Zhou SC, Li RB, Ren Y, Ka-Lun LO, Xu RY, Chen JR, Lan D, Gao JL, Chu SG, Jin ZC, Huang FF, Shi ZK, Yang QW, Zhou H, Wang SD, Ji TR, Han QP, Wang CM, Chi-Fai NG, Wang HF; APROPOS Group. Perineal nerve block versus periprostatic block for patients undergoing transperineal prostate biopsy (APROPOS): a prospective, multicentre, randomised controlled study. EClinicalMedicine. 2023 Mar 23;58:101919. doi: 10.1016/j.eclinm.2023.101919. eCollection 2023 Apr. | |
| 34692757 |
Not provided
Not provided
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.
Data will become available after publication with no end date
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| Guang'an people's hospital of Sichuan province |
| OTHER |
| Chinese University of Hong Kong | OTHER |
| Chongqing Medical University | OTHER |
Not provided
Not provided
Not provided
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.
| periprostatic block |
| Behavioral |
An anesthesia method to block periprostate |
|
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 |
| Derived |
| 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |