Anesthesia in PROstate Biopsy Pain Obstruction Study

NCT04501055 | Completed DMC

• 1 other identifier: APROPOS-01
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; transperineal prostate biopsy; perineal nerve block; periprostatic block; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• The pain in 1,6, and 12 hours after the biopsy

  1,6, and 12 hours after the biopsy

• Changes in blood pressure during biopsy procedure

  During the biopsy procedure

• Changes in heart rate during biopsy procedure

  During the biopsy procedure

• Changes in breath rate during biopsy procedure

  During the biopsy procedure

• The detection rate for prostate cancer

  within 1 month after the biopsy

Study Arms (2)

Perineal nerve block

EXPERIMENTAL

Man receive the perineal nerve block before under the transperineal prostate biopsy

Behavioral: perineal nerve block

Periprostatic block

ACTIVE COMPARATOR

Man receive the periprostatic block before under the transperineal prostate biopsy

Behavioral: periprostatic block

Interventions

perineal nerve block BEHAVIORAL

An anesthesia method to block perineal nerve

Perineal nerve block

periprostatic block BEHAVIORAL

An anesthesia method to block periprostate

Periprostatic block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Shi Shi Municipal General Hospital: collaborator
• People's Hospital of Yiyuan County: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: collaborator
• Guang'an people's hospital of Sichuan province: collaborator
• Chinese University of Hong Kong: collaborator
• Chongqing Medical University: collaborator

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

Related Publications (2)

• 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.

  PMID: 37007736 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.

  PMID: 34692757 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Haifeng Wang

  Shanghai East Hospital,Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: August 13, 2020
• Primary Completion: July 20, 2022
• Study Completion: July 27, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after publication with no end date

Locations

CN (1)