Open randomized clinical trial to examine individual pain tolerance in the use of two anesthetic techniques to perform extended prostate biopsy .

Phase 1

Conditions: Prostate biopsy anesthesia
MedDRA version: 18.1Level: LLTClassification code 10004825Term: Biopsy of prostateSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2015-003740-39-ES

Lead Sponsor: Jose Luis Ponce Díaz-Reixa

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 100

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.
-Pre-anesthetic consultation to all patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS ), to obtain saturation prostate biopsies .;Secondary Objective: To assess the safety of the procedure and complications in the use of each of the anesthetic techniques during saturation prostate biopsy;Primary end point(s): To determinate a difference in pain of 1.4 ± 2.5 on the visual analog scale (pain under sedation 0.5 vs. 1.9 with locoregional), with 80 % power and 95 % confidence .;Timepoint(s) of evaluation of this end point: Basal time: Pain at baseline , before any anesthetic procedure or urological manipulation. Scale of 0-10 .<br>End time: Pain after the procedure, the patient leaving the operating room. Scale of 0-10 .

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Presence of medication side effects of the procedure : nausea or vomiting , hypotension or hypertension and / or bradycardia or tachycardia .<br>- Presence of secondary complications to the procedure : hematuria , urinary difficulty, urinary retention, urinary tract infection and / or sepsis . The use of additional pain medication in the post- procedure is also measured.;Timepoint(s) of evaluation of this end point: Time interval between final procedure and 24 hours after the procedure.