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

Complexo Hospitalario Universitario de A Coruña

Status and phase: Completed; Phase 4

Conditions: Prostatic Cancer

Treatments: Drug: FENTANILE; Drug: KETAMINE; Drug: MEPIVACAÍNE; Drug: MIDAZOLAM

Study type: Interventional

Funder types: Other

Identifiers

NCT02909049

URO - CHUAC - BPSat - 001.

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CONTROL

Active Comparator group

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

Treatment:

Drug: MIDAZOLAM

Drug: KETAMINE

Drug: FENTANILE

EXPERIMENTAL

Experimental group

Description:

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

Treatment:

Drug: MEPIVACAÍNE