Anesthesia Clinical Trial
— SPINAL-USOfficial title:
The Use of Ultrasound to Predict a Difficult Spinal Anesthesia: a Prospective Single-blind Observational Study
NCT number | NCT05115591 |
Other study ID # | 19.21 OSS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 5, 2021 |
Est. completion date | September 15, 2021 |
Verified date | November 2021 |
Source | Campus Bio-Medico University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This prospective observational study aims to investigate about the efficacy of spine ultrasound in predicting difficult spinal anesthesia
Status | Completed |
Enrollment | 100 |
Est. completion date | September 15, 2021 |
Est. primary completion date | September 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing spinal anesthesia for elective surgery - ASA physical status score < 4 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Università Campus Biomedico | Roma |
Lead Sponsor | Collaborator |
---|---|
Campus Bio-Medico University |
Italy,
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. — View Citation
Del Buono R, Pascarella G, Costa F, Terranova G, Leoni ML, Barbara E, Carassiti M, Agrò 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. — View Citation
Weed 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultrasound View | Ultrasound visibility of Dura Mater complexes on the intervertebral space chosen for spinal anesthesia | 10 minutes | |
Primary | 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. | 20 minutes | |
Secondary | Failure Rate | Failed Spinal Anesthesia | 20 minutes | |
Secondary | Duration | Spinal anesthesia duration (expressed in seconds) from the insertion of the needle to the deliquoration | 20 minutes | |
Secondary | Spinal needle replacements | Number of needle replacements | 20 minutes |
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