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

Phase 4

Completed

• Conditions: Prostatic Cancer
• Interventions: Drug: MEPIVACAÍNE; Drug: MIDAZOLAM; Drug: FENTANILE; Drug: KETAMINE

• Registration Number: NCT02909049
• Lead Sponsor: Complexo Hospitalario Universitario de A Coruña

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Status Verified: 2018-01
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	FENTANILE	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
EXPERIMENTAL	MEPIVACAÍNE	Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.
CONTROL	MIDAZOLAM	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
CONTROL	KETAMINE	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

Primary Outcome Measures

Name	Time	Method
Change in visual analog scale (VAS)	1 hour baseline	Change in visual analog scale (VAS) from baseline and after prostate biopsy

Secondary Outcome Measures

Name	Time	Method
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.	One week	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.

Trial Locations

Locations (1)

Jose Luis Ponce Diaz-Reixa; 🇪🇸 A Coruña, Spain