Anesthesia in PROstate Biopsy Pain Obstruction Study
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: perineal nerve blockBehavioral: periprostatic block
- Registration Number
- NCT04501055
- Lead Sponsor
- Shanghai East Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 192
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Perineal nerve block perineal nerve block Man receive the perineal nerve block before under the transperineal prostate biopsy Periprostatic block periprostatic block Man receive the periprostatic block before under the transperineal prostate biopsy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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).
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
Trial Locations
- Locations (1)
Shanghai East Hospital, Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China