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

Complexo Hospitalario Universitario de A Coruña100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Prostatic Cancer

Interventions

MIDAZOLAMDRUG

Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.

MEPIVACAÍNEDRUG

Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.

FENTANILEDRUG

Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jose Luis Ponce Diaz-Reixa

A Coruña, Spain

Outcomes

Primary Outcomes

Change in visual analog scale (VAS)

Change in visual analog scale (VAS) from baseline and after prostate biopsy

Time frame: 1 hour baseline

Secondary Outcomes

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.

Time frame: One week

Data from ClinicalTrials.gov

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