Clinical trial NCT05649020: ED50 of Intratecal Prilocaine in Ultrasound Fusion Prostate Biopsy
Official title: ED50 of Intrathecal Hyperbaric 2% Prilocaine in Transperineal Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Guided Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy
Keywords: ED50
hyperbaric prilocaine
ultrasound fusion guided prostate biopsy
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: To evaluate the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: ED50 of intrathecal hyperbaric 2% prilocaine in transperineal magnetic resonance imaging-transrectal ultrasound fusion guided biopsy
timeFrame: From the baseline, previous to prilocaine adminstration until the end of the prostate biopsy procedure. 30 minutes
Secondary outcomes:
measure: To analyze the hemodynamic response during surgery
timeFrame: From the baseline previous to prilocaine adminstration until the end of the prostate biopsy. 30 minutes
measure: acute urinary retention
timeFrame: From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure
measure: length of stay in the facility
timeFrame: From the baseline previous to prilocaine adminstration until the patient meets discharge criteria, defined by complete regression of sensory block.
measure: incidence of unplanned admissions
timeFrame: From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
Study officials:
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