ED50 of Intratecal Prilocaine in Ultrasound Fusion Prostate Biopsy

Phase 4

Recruiting

• Conditions: Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy
• Interventions: Drug: Dose of prilocaine

• Registration Number: NCT05649020
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-24
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-13
• Last Update Posted: 2022-12-13
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Prilocaine dose	Dose of prilocaine	to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.

Primary Outcome Measures

Name	Time	Method
ED50 of intrathecal hyperbaric 2% prilocaine in transperineal magnetic resonance imaging-transrectal ultrasound fusion guided biopsy	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 Outcome Measures

Name	Time	Method
incidence of unplanned admissions	From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure	To know the incidence of patients who cannot be discharged from the unit.
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.	Time to eligibility for home discharge,
To analyze the hemodynamic response during surgery	From the baseline previous to prilocaine adminstration until the end of the prostate biopsy. 30 minutes	To evaluate the incidence of hypertension, hypotension, bradycardia or tachycardia during the prostate biopsy procedure.
acute urinary retention	From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure	Evaluate the incidence of urinary retention

Trial Locations

Locations (1)

Hospital Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain