ED50 of Intrathecal Hyperbaric 2% Prilocaine in Transperineal Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Guided Biopsy
Overview
- Phase
- Phase 4
- Intervention
- Dose of prilocaine
- Conditions
- Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy
- Sponsor
- Hospital General Universitario Gregorio Marañon
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- ED50 of intrathecal hyperbaric 2% prilocaine in transperineal magnetic resonance imaging-transrectal ultrasound fusion guided biopsy
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of the present study was to determine the ED50 and ED90 of intrathecal hyperbaric 2% prilocaine (HP) for patients undergoing ambulatory prostate biopsy via magnetic resonance imaging (MRI)/ultrasound fusion.
Detailed Description
Prostate biopsy to diagnose or exclude cancer is currently performed an estimated one million times annually worldwide. In this method, the operator images the prostate using ultrasound, as performed for the past several decades; while thus viewing the prostate, the MRI of that prostate, which is performed beforehand and stored in the device, is fused with real-time ultrasound using a digital overlay, allowing the target(s), previously delineated by a radiologist, to be brought into the aiming mechanism of the ultrasound machine. The fusion results in creation of a three-dimensional reconstruction of the prostate, and on the reconstructed model, the aiming and tracking of biopsy sites occurs. This method needs for sedation/general/ spinal anesthesia because of patient discomfort with the transperineal approach of the biopsy needle passing through the perineum. Even though the MRI/ultrasound fusión prostate biopsy is widespread used, the anaesthetic techniques for this procedure are not standardised. Hyperbaric prilocaine is an amide-type local anesthetic widely used in short surgical procedures showing its efficacy for outpatient surgery. The proposed intrathecal doses of prilocaine for various surgical procedures range from 10 to 80 mg. Thus, even though the drug is in clinical use, optimal doses of HP required for specific types of surgery warrant further refinement. The aim of the present study was to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.
Investigators
Matilde Zaballos
Professor
Hospital General Universitario Gregorio Marañon
Eligibility Criteria
Inclusion Criteria
- •ASA II-III patients Aged 18-85 years Prostate fusion biopsy procedure Scheduled to ambulatory surgery Signed informed consent
Exclusion Criteria
- •Standard contraindications to neuraxial blockade, coagulopathy, site infection, neurological impairment, known allergy to local anesthetics. Refusal of the patient to participate in the study.
Arms & Interventions
Prilocaine dose
to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.
Intervention: Dose of prilocaine
Outcomes
Primary Outcomes
ED50 of intrathecal hyperbaric 2% prilocaine in transperineal magnetic resonance imaging-transrectal ultrasound fusion guided biopsy
Time Frame: From the baseline, previous to prilocaine adminstration until the end of the prostate biopsy procedure. 30 minutes
to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.
Secondary Outcomes
- acute urinary retention(From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure)
- incidence of unplanned admissions(From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure)
- length of stay in the facility(From the baseline previous to prilocaine adminstration until the patient meets discharge criteria, defined by complete regression of sensory block.)
- To analyze the hemodynamic response during surgery(From the baseline previous to prilocaine adminstration until the end of the prostate biopsy. 30 minutes)