AnesthesiaSPINAL-USNCT05115591
Ultrasound Predictors of Difficult Spinal Anesthesia
An observational study of Anesthesia and Procedural Complication, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
This prospective observational study aims to investigate about the efficacy of spine ultrasound in predicting difficult spinal anesthesia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Procedural Complication
- What is being tested?
- Spinal Ultrasound and Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2021to 15 Sep 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing spinal anesthesia for elective orthopedic and urologic surgery
Who may be able to join
- Patients undergoing spinal anesthesia for elective surgery
- ASA physical status score < 4
Who cannot join
- Contraindications to regional anesthesia
- ASA physical status score ≥ 4
- Patient's refusal or inability to sing the informed consent
- Previous spine surgery affecting the intervertebral space chosen for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Ultrasound to Predict a Difficult Spinal Anesthesia: a Prospective Single-blind Observational Study
This prospective observational study aims to investigate about the efficacy of spine ultrasound in predicting difficult spinal anesthesia
- Conditions
- Anesthesia, Procedural Complication
- Being tested
- Spinal Ultrasound, Spinal Anesthesia
- Keywords
- Spinal Anesthesia, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal UltrasoundDiagnostic test
Spinal Ultrasound is performed by an observer who records ultrasound characteristics of the intervertebral space chosen by the anesthetist who will practice spinal anesthesia
Spinal AnesthesiaProcedure or surgery
Spinal anesthesia is performed by an anesthetist after the observer recorded ultrasound characteristics of the intervertebral space chosen by the anesthetist, who is blinded to the ultrasound evaluation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound View
Ultrasound visibility of Dura Mater complexes on the intervertebral space chosen for spinal anesthesia
Measured: 10 minutes
Difficulty in performing spinal anesthesia
Difficult spinal anesthesia includes: failure, procedure lasting more than 400 seconds from the insertion of the needle to the deliquoration; a number of needle replacements greater than 10; a change of the clinician practicing spinal anesthesia.
Measured: 20 minutes
Secondary outcomes (3)
Failure Rate
Failed Spinal Anesthesia
Measured: 20 minutes
Duration
Spinal anesthesia duration (expressed in seconds) from the insertion of the needle to the deliquoration
Measured: 20 minutes
Spinal needle replacements
Number of needle replacements
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start5 Mar 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Pascarella, Campus Bio-Medico University
- Investigators
- Felice E Agrò, Prof., Study chair, Campus Biomedico of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115591
- Sponsor's protocol ID
- 19.21 OSS
- Acronym
- SPINAL-US
- Status last verified
- Nov 2021
- First submitted
- 30 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chin KJ, Ramlogan R, Arzola C, Singh M, Chan V. The utility of ultrasound imaging in predicting ease of performance of spinal anesthesia in an orthopedic patient population. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):34-8. doi: 10.1097/AAP.0b013e3182734927.
PubMed 23143015Weed JT, Taenzer AH, Finkel KJ, Sites BD. Evaluation of pre-procedure ultrasound examination as a screening tool for difficult spinal anaesthesia*. Anaesthesia. 2011 Oct;66(10):925-30. doi: 10.1111/j.1365-2044.2011.06834.x. Epub 2011 Jul 25.
PubMed 21790522Del Buono R, Pascarella G, Costa F, Terranova G, Leoni ML, Barbara E, Carassiti M, Agro FE. Predicting difficult spinal anesthesia: development of a neuraxial block assessment score. Minerva Anestesiol. 2021 Jun;87(6):648-654. doi: 10.23736/S0375-9393.20.14892-2. Epub 2020 Dec 16.
PubMed 33325214
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasound to Predict a Difficult Spinal Anesthesia: a Prospective Single-blind Observational Study
- ClinicalTrials.gov ID
- NCT05115591
- Acronym / sponsor ID
- SPINAL-US / 19.21 OSS
- Conditions
- Anesthesia, Procedural Complication
- Keywords
- Spinal Anesthesia, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 10 Nov 2021 (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.
This prospective observational study aims to investigate about the efficacy of spine ultrasound in predicting difficult spinal anesthesia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing spinal anesthesia for elective orthopedic and urologic surgery
Key inclusion criteria (2 listed)
- Patients undergoing spinal anesthesia for elective surgery
- ASA physical status score < 4
Key exclusion criteria (4 listed)
- Contraindications to regional anesthesia
- ASA physical status score ≥ 4
- Patient's refusal or inability to sing the informed consent
- Previous spine surgery affecting the intervertebral space chosen for spinal anesthesia
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 |
|---|---|---|
| Spinal UltrasoundSpinal Ultrasound is performed by an observer who records ultrasound characteristics of the intervertebral space chosen by the anesthetist who will practice spinal anesthesia | Diagnostic test | – |
| Spinal AnesthesiaSpinal anesthesia is performed by an anesthetist after the observer recorded ultrasound characteristics of the intervertebral space chosen by the anesthetist, who is blinded to the ultrasound evaluation. | Procedure or surgery | – |
Primary outcome
Ultrasound View
Time frame: 10 minutes
Ultrasound visibility of Dura Mater complexes on the intervertebral space chosen for spinal anesthesia
Difficulty in performing spinal anesthesia
Time frame: 20 minutes
Difficult spinal anesthesia includes: failure, procedure lasting more than 400 seconds from the insertion of the needle to the deliquoration; a number of needle replacements greater than 10; a change of the clinician practicing spinal anesthesia.
3 secondary outcomes
Failure Rate
Time frame: 20 minutes
Duration
Time frame: 20 minutes
Spinal needle replacements
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Background: PubMed 23143015Chin KJ, Ramlogan R, Arzola C, Singh M, Chan V. The utility of ultrasound imaging in predicting ease of performance of spinal anesthesia in an orthopedic patient population. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):34-8. doi: 10.1097/AAP.0b013e3182734927.
- Background: PubMed 21790522Weed JT, Taenzer AH, Finkel KJ, Sites BD. Evaluation of pre-procedure ultrasound examination as a screening tool for difficult spinal anaesthesia*. Anaesthesia. 2011 Oct;66(10):925-30. doi: 10.1111/j.1365-2044.2011.06834.x. Epub 2011 Jul 25.
- Background: PubMed 33325214Del Buono R, Pascarella G, Costa F, Terranova G, Leoni ML, Barbara E, Carassiti M, Agro FE. Predicting difficult spinal anesthesia: development of a neuraxial block assessment score. Minerva Anestesiol. 2021 Jun;87(6):648-654. doi: 10.23736/S0375-9393.20.14892-2. Epub 2020 Dec 16.
- Individual participant dataSharing planned: Undecided
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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.
Felice E Agrò, Prof. study chair
Campus Biomedico of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Procedural Complication, run by Campus Bio-Medico University at 1 site in Italy.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound View (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 NCT05115591, which also lists 3 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 18 Nov 2021.