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

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

Sponsors

Lead sponsor: Complexo Hospitalario Universitario de A Coruña

Source Complexo Hospitalario Universitario de A Coruña
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.

Overall Status Completed
Start Date April 2016
Completion Date January 24, 2018
Primary Completion Date January 24, 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in visual analog scale (VAS) 1 hour baseline
Secondary Outcome
Measure Time Frame
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
Enrollment 100
Condition
Intervention

Intervention type: Drug

Intervention name: MIDAZOLAM

Description: Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.

Arm group label: CONTROL

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

Intervention type: Drug

Intervention name: MEPIVACAÍNE

Description: Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.

Arm group label: EXPERIMENTAL

Other name: MEPIVACAINE 2% ATC N01BB03 MAN 62606

Intervention type: Drug

Intervention name: FENTANILE

Description: Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.

Arm group label: CONTROL

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

Intervention type: Drug

Intervention name: KETAMINE

Description: Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Arm group label: CONTROL

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

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.

Gender: Male

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jose L Ponce, MD Principal Investigator Complejo Hospitalario Universitario A Coruña
Location
facility
Jose Luis Ponce Diaz-Reixa
Location Countries

Spain

Verification Date

January 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Complexo Hospitalario Universitario de A Coruña

Investigator full name: José Luis Ponce Díaz-Reixa

Investigator title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CONTROL

Arm group type: Active Comparator

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

Arm group label: EXPERIMENTAL

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov