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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 19, 2016
First Posted Date  ICMJE September 21, 2016
Last Update Posted Date January 26, 2018
Study Start Date  ICMJE April 2016
Actual Primary Completion Date January 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
Change in visual analog scale (VAS) [ Time Frame: 1 hour baseline ]
Change in visual analog scale (VAS) from baseline and after prostate biopsy
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
Change in visual analog scale (VAS) [ Time Frame: 1 hour ]
Change in visual analog scale (VAS) from baseline and after prostate biopsy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
Official Title  ICMJE Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Cancer
Intervention  ICMJE
  • Drug: MIDAZOLAM
    Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
    Other Name: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319
  • Drug: MEPIVACAÍNE
    Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
    Other Name: MEPIVACAINE 2% ATC N01BB03 MAN 62606
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: MIDAZOLAM
    • Drug: FENTANILE
    • Drug: KETAMINE
  • Experimental: EXPERIMENTAL
    Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.
    Intervention: Drug: MEPIVACAÍNE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 24, 2018
Actual Primary Completion Date January 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02909049
Other Study ID Numbers  ICMJE URO - CHUAC - BPSat - 001.
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party José Luis Ponce Díaz-Reixa, Complexo Hospitalario Universitario de A Coruña
Study Sponsor  ICMJE Complexo Hospitalario Universitario de A Coruña
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose L Ponce, MD Complejo Hospitalario Universitario A Coruña
PRS Account Complexo Hospitalario Universitario de A Coruña
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP