Ultrasound Predictors of Difficult Spinal Anesthesia

NCT05115591 | Completed DMC

• 1 other identifier: 19.21 OSS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia; Procedural Complication

Keywords

Spinal Anesthesia; Ultrasound

Outcome Measures

Primary Outcomes (2)

• Ultrasound View

  Ultrasound visibility of Dura Mater complexes on the intervertebral space chosen for spinal anesthesia

  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.

  20 minutes

Secondary Outcomes (3)

• Failure Rate

  20 minutes

• Duration

  20 minutes

• Spinal needle replacements

  20 minutes

Interventions

Spinal Ultrasound DIAGNOSTIC_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 Anesthesia PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing spinal anesthesia for elective orthopedic and urologic surgery

You may qualify if:

• Patients undergoing spinal anesthesia for elective surgery
• ASA physical status score \< 4

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Università Campus Biomedico

Roma, Italy

Location

Related 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.

  PMID: 23143015 BACKGROUND

• 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.

  PMID: 21790522 BACKGROUND

• Del 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.

  PMID: 33325214 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Felice E Agrò, Prof.

  Campus Biomedico of Rome

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 10, 2021
• Study Start: March 5, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

IT (1)