Clinical trial · Interventional
Anesthesia in PROstate Biopsy Pain Obstruction Study
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
NCT04501055CI-TRIAL-00061797APROPOScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perineal nerve block | Behavioral | — | UNRESOLVED |
| periprostatic block | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Perineal nerve block
- description
- Man receive the perineal nerve block before under the transperineal prostate biopsy
- interventionNames
- Behavioral: perineal nerve block
- type
- ACTIVE_COMPARATOR
- label
- Periprostatic block
- description
- Man receive the periprostatic block before under the transperineal prostate biopsy
- interventionNames
- Behavioral: periprostatic block
Primary outcomes (1)
- measure
- The pain of the biopsy procedure
- timeFrame
- within10 minutes after the prostate biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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;
References
Publications (2)
- DERIVEDHe 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
- DERIVEDHe 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