Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy

Study Overview
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Brief Summary
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To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.

Detailed Description
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To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies. Anesthetic technique (control) - Intravenous sedation with Midazolam, Fentanile and Ketamine. Anesthetic technique (intervention) - Regional Mepivacaine infiltration of periprostatic region.

Official Title
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Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy

Conditions
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Prostatic Cancer

Intervention / Treatment
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* Drug: MIDAZOLAM
* Drug: MEPIVACAÍNE
* Drug: FENTANILE
* Drug: KETAMINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CONTROL<br>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 | Drug: MIDAZOLAM<br>* Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.<br>* Other names: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319;Drug: FENTANILE<br>* Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.<br>* Other names: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764;Drug: KETAMINE<br>* Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.<br>* Other names: KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034;|
| Experimental: EXPERIMENTAL<br>Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally. | Drug: MEPIVACAÍNE<br>* Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.<br>* Other names: MEPIVACAINE 2% ATC N01BB03 MAN 62606;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual analog scale (VAS) | Change in visual analog scale (VAS) from baseline and after prostate biopsy | 1 hour baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with complications after anesthesic procedure and prostate biopsy procedure, after 24 hours of the procedure and at end of study visit. All units will be measured as numbers. | To assess the safety of the procedure and complications in the use of each of the anesthetic techniques during saturation prostate biopsy. Safety events will be measured during saturation prostate biopsy and after recovery, during 24 hours. Number of patients with complications after anesthesic procedure and prostate biopsy procedure. Number of patients with complications after 24 hours of the procedure. Number of patients with complications at end of study visit. | One week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Biopsy, Local Anesthesia, Pain, Biopsy of prostate