Clinical trial · Interventional
Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
NCT02909049CI-TRIAL-00031410completedPhase 4ClinicalTrials.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)
To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.
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 |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FENTANILE | Drug | — | UNRESOLVED |
| KETAMINE | Drug | — | UNRESOLVED |
| MEPIVACAÍNE | Drug | — | UNRESOLVED |
| MIDAZOLAM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CONTROL
- description
- Saturation prostate biopsy under intravenous sedation MIDAZOLAM 1,5 mg per kilogram intravenous, 5 minutes prior to biopsy FENTANILE 0,05 mg per kilogram intravenous, 3 minutes prior to biopsy KETAMINE 0.5 mg per kilogram intravenous, 1 minute prior to biopsy
- interventionNames
- Drug: MIDAZOLAM
- Drug: FENTANILE
- Drug: KETAMINE
- type
- EXPERIMENTAL
- label
- EXPERIMENTAL
- description
- Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.
- interventionNames
- Drug: MEPIVACAÍNE
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male patient * Persistence of suspected prostate cancer by altering the prostatic specific antigen and / or digital rectal examination. * Two previous negative prostate biopsies . * Age \< 75 years. * Signature of informed consent to perform prostate biopsy. * Signature of informed consent for the study. Exclusion Criteria: * Age \> 75 years. * Absence of consent or refusal to the study . * Presence of prostate cancer in previous biopsy observation . * Medical-surgical patient's problems, absolutely contraindicating biopsy under local anesthesia. * Presence of any allergies to medications involved in the study . * Patient's clinical situation that does not allow an outpatient operation and aftercare required . * Medical condition of the patient, preventing the realization of outpatient biopsy. * No companion.
References
Publications (0)
Data not yet available
No reference posted for this study.