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

Sponsor

Complexo Hospitalario Universitario de A Coruña (Other)

Overall Status

Completed

CT.gov ID

NCT02909049

Collaborator

(none)

100

Enrollment

Location

Arms

21.8

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Cancer	Drug: MIDAZOLAM Drug: MEPIVACAÍNE Drug: FENTANILE Drug: KETAMINE	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Jan 24, 2018

Actual Study Completion Date :

Jan 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: MIDAZOLAM Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy. Other Names: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319 Drug: FENTANILE Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy. Other Names: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764 Drug: KETAMINE Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy. Other Names: KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034
Experimental: EXPERIMENTAL Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.	Drug: MEPIVACAÍNE Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy. Other Names: MEPIVACAINE 2% ATC N01BB03 MAN 62606

Arm

Intervention/Treatment

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

Drug: MIDAZOLAM

Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.

Other Names:

MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319

Drug: FENTANILE

Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.

Other Names:

FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764

Drug: KETAMINE

Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Other Names:

KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034

Experimental: EXPERIMENTAL

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

Drug: MEPIVACAÍNE

Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.

Other Names:

MEPIVACAINE 2% ATC N01BB03 MAN 62606

Outcome Measures

Primary Outcome Measures

Change in visual analog scale (VAS) [1 hour baseline]
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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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.