Ultrasound Predictors of Difficult Spinal Anesthesia (SPINAL-US)

November 11, 2021 updated by: Giuseppe Pascarella, Campus Bio-Medico University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Università Campus Biomedico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing spinal anesthesia for elective orthopedic and urologic surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound View
Time Frame: 10 minutes
Ultrasound visibility of Dura Mater complexes on the intervertebral space chosen for spinal anesthesia
10 minutes
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.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure Rate
Time Frame: 20 minutes
Failed Spinal Anesthesia
20 minutes
Duration
Time Frame: 20 minutes
Spinal anesthesia duration (expressed in seconds) from the insertion of the needle to the deliquoration
20 minutes
Spinal needle replacements
Time Frame: 20 minutes
Number of needle replacements
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Investigators

  • Study Chair: Felice E Agrò, Prof., Campus Biomedico of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

October 30, 2021

First Submitted That Met QC Criteria

October 30, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 11, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.21 OSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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