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ED50 of Intratecal Prilocaine in Ultrasound Fusion Prostate Biopsy

NCT ID: NCT05649020

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy

Keywords

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ED50 hyperbaric prilocaine ultrasound fusion guided prostate biopsy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

To evaluate the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

The nurse blinded to the dose, was absent during the procedure and assessed each block. Furthermore, all patients were unaware of the injected dose of HP.

Study Groups

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Prilocaine dose

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

Group Type OTHER

Dose of prilocaine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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ED50 of intrathecal hyperbaric prilocaine in ultrasound fusion guided prostate biopsy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role lead

Responsible Party

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Matilde Zaballos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Gregorio Maranon

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Gregorio Maranon

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Matilde Zaballos, MD, PhD

Role: CONTACT

Phone: 34657813987

Email: [email protected]

Maria De la Cruz, PhD

Role: CONTACT

Phone: 0034914269232

Email: [email protected]

Facility Contacts

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Matilde Zaballos, MDPhD

Role: primary

Maria De La Cruz, PhD

Role: backup

Matilde Zaballos, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 2052197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23199005 (View on PubMed)

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.

Reference Type RESULT
PMID: 24906303 (View on PubMed)

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.

Reference Type RESULT
PMID: 20529983 (View on PubMed)

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.

Reference Type RESULT
PMID: 27352633 (View on PubMed)

Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.

Reference Type RESULT
PMID: 25211156 (View on PubMed)

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.

Reference Type RESULT
PMID: 19112061 (View on PubMed)

Other Identifiers

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PRILODE50-FUSION

Identifier Type: -

Identifier Source: org_study_id