Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
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|ClinicalTrials.gov Identifier: NCT02909049|
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Cancer||Drug: MIDAZOLAM Drug: MEPIVACAÍNE Drug: FENTANILE Drug: KETAMINE||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||April 2016|
|Actual Primary Completion Date :||January 24, 2018|
|Actual Study Completion Date :||January 24, 2018|
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
Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
Other Name: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319
Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
Other Name: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764
Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
Other Name: KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034
Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.
Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
Other Name: MEPIVACAINE 2% ATC N01BB03 MAN 62606
- Change in visual analog scale (VAS) [ Time Frame: 1 hour baseline ]Change in visual analog scale (VAS) from baseline and after prostate biopsy
- 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909049
|Jose Luis Ponce Diaz-Reixa|
|A Coruña, Spain, 15006|
|Principal Investigator:||Jose L Ponce, MD||Complejo Hospitalario Universitario A Coruña|