NCT02909049

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Complexo Hospitalario Universitario de A Coruña · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Cancer

Interventions

Type	Name	Description
DRUG	MIDAZOLAM	Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
DRUG	MEPIVACAÍNE	Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
DRUG	FENTANILE	Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
DRUG	KETAMINE	Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-01-24
• Completion: 2018-01-24
• First posted: 2016-09-21
• Last updated: 2018-01-26

Locations

1 site across 1 country: Spain