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

Ketamine

Brief Summary

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

Intervention / Treatment

  • Midazolam (DRUG)
    Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
  • MEPIVACAÍNE (DRUG)
    Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
  • FENTANILE (DRUG)
    Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
  • Ketamine (DRUG)
    Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Condition or Disease

  • Prostatic Cancer

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 100 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Apr 01, 2016
    Primary Completion: Jan 24, 2018 ACTUAL
    Completion Date: Jan 24, 2018 ACTUAL
    Study First Posted: Sep 21, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 25, 2018

    Sponsors / Collaborators

    Lead Sponsor: Complexo Hospitalario Universitario de A Coruña
    Responsible Party: N/A

    Location

    A Coruña, Spain

    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.

    Participant Groups

    • 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

    • Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • Change in visual analog scale (VAS) from baseline and after prostate biopsy

    Secondary Outcomes

    • 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.

    More Details

    NCT Number: NCT02909049
    Other IDs: URO - CHUAC - BPSat - 001.
    Study URL: https://clinicaltrials.gov/study/NCT02909049
    Last updated: Sep 29, 2023