Evaluate Requirements of 2% Prilocaine in MR-UF Prostate BiopsyPhase 4NCT05649020
ED50 of Intratecal Prilocaine in Ultrasound Fusion Prostate Biopsy
A Phase 4 study testing Dose of prilocaine in people with Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy, run by Hospital General Universitario Gregorio Marañon at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy
- What is being tested?
- Dose of prilocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 24 Nov 2022to 31 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II-III patients Aged 18-85 years Prostate fusion biopsy procedure Scheduled to ambulatory surgery Signed informed consent
Who cannot join
- Standard contraindications to neuraxial blockade, coagulopathy, site infection, neurological impairment, known allergy to local anesthetics. Refusal of the patient to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Gregorio Maranon
Madrid, 28007
Matilde Zaballos, MDPhD, 0034657813987, mati@plagaro.net
Maria De La Cruz, PhD, 0034914269232, ucaicec@fibhgm.org
- Recruiting
Hospital Universitario Gregorio Maranon
Madrid, 28007
Matilde Zaballos, MD, PhD, 0034915868367, mati@plagaro.net
About this study
Official title: 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.
Read the 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.
- Being tested
- Dose of prilocaine
- Keywords
- ED50, hyperbaric prilocaine, ultrasound fusion guided prostate biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of prilocaineDrug
Also called ED50 of intrathecal hyperbaric prilocaine in ultrasound fusion guided prostate biopsy
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.
| Study group | Role | What they receive |
|---|---|---|
| Prilocaine dose | Other | to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy. Receives: Drug: Dose of prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the baseline, previous to prilocaine adminstration until the end of the prostate biopsy procedure. 30 minutes
Secondary outcomes (4)
To analyze the hemodynamic response during surgery
To evaluate the incidence of hypertension, hypotension, bradycardia or tachycardia during the prostate biopsy procedure.
Measured: 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
Measured: 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,
Measured: 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.
Measured: From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start24 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Evaluate Requirements of 2% Prilocaine in MR-UF Prostate BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- To evaluate the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matilde Zaballos, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649020
- Sponsor's protocol ID
- PRILODE50-FUSION
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan is intended
Publications
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.
PubMed 2052197Gebhardt 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.
PubMed 23199005Guntz 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.
PubMed 24906303Camponovo 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.
PubMed 20529983Boublik 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.
PubMed 27352633Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.
PubMed 25211156Hendriks 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.
PubMed 19112061
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED50 of Intrathecal Hyperbaric 2% Prilocaine in Transperineal Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Guided Biopsy
- ClinicalTrials.gov ID
- NCT05649020
- Acronym / sponsor ID
- PRILODE50-FUSION
- Keywords
- ED50, hyperbaric prilocaine, ultrasound fusion guided prostate biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.
| Arm | Type | Receives |
|---|---|---|
| Prilocaine dose | Other | Drug: Dose of prilocaineto determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA II-III patients Aged 18-85 years Prostate fusion biopsy procedure Scheduled to ambulatory surgery Signed informed consent
Key exclusion criteria (1 listed)
- Standard contraindications to neuraxial blockade, coagulopathy, site infection, neurological impairment, known allergy to local anesthetics. Refusal of the patient to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose of prilocaineAlso: ED50 of intrathecal hyperbaric prilocaine in ultrasound fusion guided prostate biopsyWith 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. | Drug | Prilocaine dose |
Primary outcome
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.
4 secondary outcomes
To analyze the hemodynamic response during surgery
Time frame: From the baseline previous to prilocaine adminstration until the end of the prostate biopsy. 30 minutes
acute urinary retention
Time frame: From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure
length of stay in the facility
Time frame: From the baseline previous to prilocaine adminstration until the patient meets discharge criteria, defined by complete regression of sensory block.
incidence of unplanned admissions
Time frame: From the baseline previous to prilocaine adminstration until the first 24 hours after the prostate biopsy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Background: PubMed 2052197Dixon 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.
- Background: PubMed 23199005Gebhardt 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.
- Results publication: PubMed 24906303Guntz 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.
- Results publication: PubMed 20529983Camponovo 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.
- Results publication: PubMed 27352633Boublik 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.
- Results publication: PubMed 25211156Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.
- Results publication: PubMed 19112061Hendriks 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.
- Individual participant dataSharing planned: No. No IPD sharing plan is intended
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dose of prilocaine in people with Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy, run by Hospital General Universitario Gregorio Marañon at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matilde Zaballos, MD, PhD (34657813987, mati@plagaro.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649020, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.