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

January 25, 2018 updated by: José Luis Ponce Díaz-Reixa, Complexo Hospitalario Universitario de A Coruña

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Jose Luis Ponce Diaz-Reixa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual analog scale (VAS)
Time Frame: 1 hour baseline
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.
Time Frame: 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.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complexo Hospitalario Universitario de A Coruña

Investigators

  • Principal Investigator: Jose L Ponce, MD, Complejo Hospitalario Universitario, A Coruña

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 24, 2018

Study Completion (Actual)

January 24, 2018

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO - CHUAC - BPSat - 001.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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