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OpenTrials
Completed

NCT Number: NCT05115591

Ultrasound Predictors of Difficult Spinal Anesthesia

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

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Key information

Conditions

Anesthesia Procedural Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università Campus Biomedico

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Ultrasound View

    Time frame: 10 minutes

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

  2. 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.

Secondary outcomes

  1. Failure Rate

    Time frame: 20 minutes

    Failed Spinal Anesthesia

  2. Duration

    Time frame: 20 minutes

    Spinal anesthesia duration (expressed in seconds) from the insertion of the needle to the deliquoration

  3. Spinal needle replacements

    Time frame: 20 minutes

    Number of needle replacements

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Acronym: SPINAL-US

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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