Clinical trial · Interventional
Intraprostatic Anesthesia During Transperineal Prostate Biopsy
The Effect of Intraprostatic Local Anesthesia on Pain Perception During Transperineal Prostate Biopsy Under Local Anesthesia
- 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)
Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to undergo repeat biopsy when necessary. This prospective randomized controlled study aims to evaluate whether the addition of intraprostatic local anesthesia to standard perineal local anesthesia reduces pain during transperineal prostate biopsy. Fifty patients undergoing prostate biopsy under local anesthesia will be randomized into two groups. The first group will receive standard perineal local anesthesia, while the second group will receive additional intraprostatic local anesthesia. Pain severity will be assessed before, during, and after the procedure using a visual analog scale (VAS). Anxiety and depression levels will be evaluated preoperatively using the Hospital Anxiety and Depression Scale (HADS). Patient-related factors, procedural characteristics, and post-procedural outcomes will also be recorded to identify factors associated with pain perception. The results of this study may help optimize local anesthesia techniques and improve patient comfort during transperineal prostate biopsy.
Conditions
Conditions (2)
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 (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Prostate-Specific Antigen | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Intraprostatic Local Anesthesia | Procedure | — | UNRESOLVED |
| Perineal Local Anesthesia | Procedure | — | UNRESOLVED |
| Prilocaine | Drug | — | UNRESOLVED |
| Transperineal Prostate Biopsy | Procedure | — | UNRESOLVED |
| Transrectal Ultrasound (TRUS) System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Perineal Local Anesthesia
- description
- Participants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy.
- interventionNames
- Drug: Prilocaine
- Drug: Bupivacaine
- Procedure: Perineal Local Anesthesia
- Procedure: Transperineal Prostate Biopsy
- Device: Transrectal Ultrasound (TRUS) System
- type
- EXPERIMENTAL
- label
- Perineal Plus Intraprostatic Local Anesthesia
- description
- Participants receive standard perineal local anesthesia plus intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes before transperineal prostate biopsy.
- interventionNames
- Drug: Prilocaine
- Drug: Bupivacaine
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients aged 18 years or older * Clinical indication for transperineal prostate biopsy based on elevated prostate-specific antigen (PSA) level and/or suspicious digital rectal examination findings * Ability to understand and complete the Hospital Anxiety and Depression Scale (HADS) * Ability to provide pain scores using a 10-point Visual Analog Scale (VAS) * Provision of written informed consent Exclusion Criteria: * Previous history of prostate biopsy * Known hypersensitivity or contraindication to local anesthetic agents * Hematological disorders affecting coagulation * Active urinary tract infection * Neurological disorders that may affect pain perception * Psychiatric disorders that may affect pain assessment or completion of study -questionnaires * Inability to complete the HADS questionnaire or VAS assessment * Refusal to participate or inability to provide informed consent
References
Publications (0)
Data not yet available