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

NCT02909049 | Completed Phase 4

• 1 other identifier: URO - CHUAC - BPSat - 001.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Cancer

Keywords

Prostate Biopsy; Local Anesthesia; Pain; Biopsy of prostate

Outcome Measures

Primary Outcomes (1)

• Change in visual analog scale (VAS)

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

  1 hour baseline

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.

  One week

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

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; Drug: FENTANILE; Drug: KETAMINE

EXPERIMENTAL

EXPERIMENTAL

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

Drug: MEPIVACAÍNE

Interventions

MIDAZOLAM DRUG

Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.

Also known as: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319

CONTROL

MEPIVACAÍNE DRUG

Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.

Also known as: MEPIVACAINE 2% ATC N01BB03 MAN 62606

EXPERIMENTAL

FENTANILE DRUG

Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.

Also known as: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764

CONTROL

KETAMINE DRUG

Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Also known as: KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034

CONTROL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Complexo Hospitalario Universitario de A Coruña: lead

Study Sites (1)

Jose Luis Ponce Diaz-Reixa

A Coruña, 15006, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Pain

Interventions

Midazolam; Mepivacaine; Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jose L Ponce, MD

  Complejo Hospitalario Universitario, A Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: September 21, 2016
• Study Start: April 1, 2016
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)