Clinical trial NCT04501055: Anesthesia in PROstate Biopsy Pain Obstruction Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
transperineal prostate biopsy
perineal nerve block
periprostatic block
anesthesia
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Shi Shi Municipal General Hospital
name: People's Hospital of Yiyuan County
name: The First Affiliated Hospital of University of Science and Technology of China
name: Guang'an people's hospital of Sichuan province
name: Chinese University of Hong Kong
name: Chongqing Medical University
First posted: 2020-08-06
Enrollment: 192
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: The pain of the biopsy procedure
timeFrame: within10 minutes after the prostate biopsy
Secondary outcomes:
measure: The pain in 1,6, and 12 hours after the biopsy
timeFrame: 1,6, and 12 hours after the biopsy
measure: Changes in blood pressure during biopsy procedure
timeFrame: During the biopsy procedure
measure: Changes in heart rate during biopsy procedure
timeFrame: During the biopsy procedure
measure: Changes in breath rate during biopsy procedure
timeFrame: During the biopsy procedure
measure: The detection rate for prostate cancer
timeFrame: within 1 month after the biopsy
measure: The detection rate for clinically significant prostate cancer
timeFrame: within 1 month after the biopsy
measure: External manifestation of pain
timeFrame: 10 minutes within biopsy
measure: Anaesthesia satisfaction
timeFrame: 24 hours after the biopsy
measure: Adverse event
timeFrame: Within 1 week after the biopsy
measure: The number of biopsy cores
timeFrame: 10 minutes within biopsy
measure: The location of each biopsy core
timeFrame: 10 minutes within biopsy
measure: Prostate volume
timeFrame: within 3 months before the biopsy procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital,Tongji University School of Medicine
name: Haifeng Wang
role: PRINCIPAL_INVESTIGATOR
References:
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.