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

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ClinicalTrials.gov Identifier: NCT02909049
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
José Luis Ponce Díaz-Reixa, 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.

Condition or disease Intervention/treatment Phase
Prostatic Cancer Drug: MIDAZOLAM Drug: MEPIVACAÍNE Drug: FENTANILE Drug: KETAMINE Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
Study Start Date : April 2016
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : January 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
Drug Information available for: Mepivacaine

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 Name: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319

Drug: FENTANILE
Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
Other Name: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764

Drug: KETAMINE
Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
Other Name: 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 Name: MEPIVACAINE 2% ATC N01BB03 MAN 62606




Primary Outcome Measures :
  1. Change in visual analog scale (VAS) [ Time Frame: 1 hour baseline ]
    Change in visual analog scale (VAS) from baseline and after prostate biopsy


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909049


Locations
Spain
Jose Luis Ponce Diaz-Reixa
A Coruña, Spain, 15006
Sponsors and Collaborators
Complexo Hospitalario Universitario de A Coruña
Investigators
Principal Investigator: Jose L Ponce, MD Complejo Hospitalario Universitario A Coruña

Responsible Party: José Luis Ponce Díaz-Reixa, MD, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT02909049     History of Changes
Other Study ID Numbers: URO - CHUAC - BPSat - 001.
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by José Luis Ponce Díaz-Reixa, Complexo Hospitalario Universitario de A Coruña:
Prostate Biopsy
Local Anesthesia
Pain
Biopsy of prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Anesthetics
Ketamine
Midazolam
Mepivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents