Ultrasound Predictors of Difficult Spinal Anesthesia

Anesthesia Clinical Trial

— SPINAL-US  

Official title:

The Use of Ultrasound to Predict a Difficult Spinal Anesthesia: a Prospective Single-blind Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115591
• Other study ID #: 19.21 OSS
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Procedural Complication

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