Prostate Cancer
Conditions
Keywords
Prostate Cancer, transperineal prostate biopsy, perineal nerve block, periprostatic block, anesthesia
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.
Interventions
BEHAVIORALperineal nerve block
An anesthesia method to block perineal nerve
BEHAVIORALperiprostatic block
An anesthesia method to block periprostate
Sponsors
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
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pain of the biopsy procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood pressure during biopsy procedure | During the biopsy procedure | The changes will be measured and recorded by multi-parameter monitoring |
| Changes in heart rate during biopsy procedure | During the biopsy procedure | The changes will be measured and recorded by multi-parameter monitoring |
| Changes in breath rate during biopsy procedure | During the biopsy procedure | The changes will be measured and recorded by multi-parameter monitoring |
| The detection rate for prostate cancer | within 1 month after the biopsy | The detection rate for any of the prostate cancer |
| The detection rate for clinically significant prostate cancer | within 1 month after the biopsy | The detection rate for prostate cancer with a ISUP\>2 |
| The pain in 1,6, and 12 hours after the biopsy | 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. |
| Anaesthesia satisfaction | 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). |
| Adverse event | Within 1 week after the biopsy | Any of the adverse events during the trial |
| The number of biopsy cores | 10 minutes within biopsy | The number of biopsy cores |
| The location of each biopsy core | 10 minutes within biopsy | The location of each biopsy core |
| Prostate volume | within 3 months before the biopsy procedure | The prostate volume will be measured by MRI before biopsy |
| External manifestation of pain | 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). |
Countries
China
Outcome results
None listed