ED50 of Intratecal Prilocaine in Ultrasound Fusion Prostate Biopsy

ED50 of Intrathecal Hyperbaric 2% Prilocaine in Transperineal Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Guided Biopsy

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.

Study Overview

• Status: Recruiting
• Conditions: Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy
• Intervention / Treatment: Drug: Dose of prilocaine

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Matilde Zaballos, MD, PhD; Phone Number: 34657813987; Email: mati@plagaro.net
• Study Contact Backup: Name: Maria De La Cruz, PhD; Phone Number: 0034914269232; Email: ucaicec@fibhgm.org

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital Universitario Gregorio Marañón
    • Contact: Matilde Zaballos, MD, PhD; Phone Number: 0034915868367; Email: mati@plagaro.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Prilocaine dose; to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.

Drug: Dose of prilocaine; With the patient in the sitting position, spinal anesthesia was performed using the midline approach at the L3-L4; L4-L5 interspace with a spinal needle. The dose of HP that a patient received was determined by the previous patient's response. If successful anesthesia was obtained, the next patient's dose was decreased. The first patient will receive a dose of 20 mg. The dose decrement/increment for each subsequent patient will be set at 2 mg. A nurse blinded to the dose, will assess the sensitive level achieved with each block. Furthermore, all patients will be unaware of the injected dose of HP. For purposes of the study, anesthesia was considered successful when there was complete loss of pinprick and cold sensation at the L1 dermatome. Values of ED 50 will be determined by calculating the midpoint concentration after at least 8 crossover points sufficient/insufficient anesthesia will be obtained. A single measurement will be obtained from each patient.; Other Names: ED50 of intrathecal hyperbaric prilocaine in ultrasound fusion guided prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED50 of intrathecal hyperbaric 2% prilocaine in transperineal magnetic resonance imaging-transrectal ultrasound fusion guided biopsy	to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.	From the baseline, previous to prilocaine adminstration until the end of the prostate biopsy procedure. 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To analyze the hemodynamic response during surgery	To evaluate the incidence of hypertension, hypotension, bradycardia or tachycardia during the prostate biopsy procedure.	From the baseline previous to prilocaine adminstration until the end of the prostate biopsy. 30 minutes
acute urinary retention	Evaluate the incidence of urinary retention	From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure
length of stay in the facility	Time to eligibility for home discharge,	From the baseline previous to prilocaine adminstration until the patient meets discharge criteria, defined by complete regression of sensory block.
incidence of unplanned admissions	To know the incidence of patients who cannot be discharged from the unit.	From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure

Collaborators and Investigators

• Sponsor: Hospital General Universitario Gregorio Marañon

Publications and helpful links

General Publications

• Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.
• Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
• Dixon WJ. Staircase bioassay: the up-and-down method. Neurosci Biobehav Rev. 1991 Spring;15(1):47-50. doi: 10.1016/s0149-7634(05)80090-9.
• Gebhardt V, Herold A, Weiss C, Samakas A, Schmittner MD. Dosage finding for low-dose spinal anaesthesia using hyperbaric prilocaine in patients undergoing perianal outpatient surgery. Acta Anaesthesiol Scand. 2013 Feb;57(2):249-56. doi: 10.1111/aas.12031. Epub 2012 Nov 30.
• Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
• Boublik J, Gupta R, Bhar S, Atchabahian A. Prilocaine spinal anesthesia for ambulatory surgery: A review of the available studies. Anaesth Crit Care Pain Med. 2016 Dec;35(6):417-421. doi: 10.1016/j.accpm.2016.03.005. Epub 2016 Jun 21.
• Hendriks MP, de Weert CJ, Snoeck MM, Hu HP, Pluim MA, Gielen MJ. Plain articaine or prilocaine for spinal anaesthesia in day-case knee arthroscopy: a double-blind randomized trial. Br J Anaesth. 2009 Feb;102(2):259-63. doi: 10.1093/bja/aen357. Epub 2008 Dec 25.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ED50; hyperbaric prilocaine; ultrasound fusion guided prostate biopsy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine
• Other Study ID Numbers: PRILODE50-FUSION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD sharing plan is intended

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No