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NCT Number: NCT02909049

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.

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Key information

Conditions

Prostatic Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Jose Luis Ponce Diaz-Reixa

A Coruña, 15006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.

Other names: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319

MEPIVACAÍNE

Drug

Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.

Other names: MEPIVACAINE 2% ATC N01BB03 MAN 62606

FENTANILE

Drug

Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.

Other names: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764

ketamine

Drug

Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Other names: KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Complexo Hospitalario Universitario de A Coruña

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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