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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2021
Source Campus Bio-Medico University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective observational study aims to investigate about the efficacy of spine ultrasound in predicting difficult spinal anesthesia


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Spinal Ultrasound
Spinal Ultrasound is performed by an observer who records ultrasound characteristics of the intervertebral space chosen by the anesthetist who will practice spinal anesthesia
Procedure:
Spinal Anesthesia
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.

Locations

Country Name City State
Italy Università Campus Biomedico Roma

Sponsors (1)

Lead Sponsor Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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

Outcome

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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