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

Primary Purpose

Prostatic Cancer

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

MIDAZOLAM

MEPIVACAÍNE

FENTANILE

KETAMINE

About this trial

This is an interventional treatment trial for Prostatic Cancer focused on measuring Prostate Biopsy, Local Anesthesia, Pain, Biopsy of prostate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Jose Luis Ponce Diaz-Reixa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CONTROL

EXPERIMENTAL

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in visual analog scale (VAS)

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02909049

First Posted

April 19, 2016

Last Updated

January 25, 2018

Sponsor

Complexo Hospitalario Universitario de A Coruña

1. Study Identification

Unique Protocol Identification Number

NCT02909049

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

January 24, 2018 (Actual)

Study Completion Date

January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Complexo Hospitalario Universitario de A Coruña

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Cancer

Keywords

Prostate Biopsy, Local Anesthesia, Pain, Biopsy of prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CONTROL

Arm Type

Active Comparator

Arm Description

Arm Title

EXPERIMENTAL

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MIDAZOLAM

Other Intervention Name(s)

MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319

Intervention Description

Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.

Intervention Type

Drug

Intervention Name(s)

MEPIVACAÍNE

Other Intervention Name(s)

MEPIVACAINE 2% ATC N01BB03 MAN 62606

Intervention Description

Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.

Intervention Type

Drug

Intervention Name(s)

FENTANILE

Other Intervention Name(s)

FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764

Intervention Description

Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.

Intervention Type

Drug

Intervention Name(s)

KETAMINE

Other Intervention Name(s)

KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034

Intervention Description

Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Primary Outcome Measure Information:

Title

Change in visual analog scale (VAS)

Description

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

Time Frame

1 hour baseline

Secondary Outcome Measure Information:

Title

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.

Description

Time Frame

One week

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose L Ponce, MD

Organizational Affiliation

Complejo Hospitalario Universitario, A Coruña

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jose Luis Ponce Diaz-Reixa

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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