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

Prostatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909049
• Other study ID #: URO - CHUAC - BPSat - 001.
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2016
• Last updated: January 25, 2018
• Start date: April 2016
• Est. completion date: January 24, 2018

Study information

• Verified date: January 2018
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Cancer
• Prostatic Neoplasms

Intervention

Drug:
• MIDAZOLAM
Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
• MEPIVACAÍNE
Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
• FENTANILE
Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
• KETAMINE
Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Locations

Country	Name	City	State
Spain	Jose Luis Ponce Diaz-Reixa	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Complexo Hospitalario Universitario de A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual analog scale (VAS)	Change in visual analog scale (VAS) from baseline and after prostate biopsy	1 hour baseline
Secondary	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