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Ultrasound Predictors of Difficult Spinal Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05115591
Acronym
SPINAL-US
Enrollment
100
Registered
2021-11-10
Start date
2021-03-05
Completion date
2021-09-15
Last updated
2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Procedural Complication

Keywords

Spinal Anesthesia, Ultrasound

Brief summary

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

Interventions

DIAGNOSTIC_TESTSpinal 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

PROCEDURESpinal 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.

Sponsors

Campus Bio-Medico University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound View10 minutesUltrasound visibility of Dura Mater complexes on the intervertebral space chosen for spinal anesthesia
Difficulty in performing spinal anesthesia20 minutesDifficult 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

MeasureTime frameDescription
Failure Rate20 minutesFailed Spinal Anesthesia
Duration20 minutesSpinal anesthesia duration (expressed in seconds) from the insertion of the needle to the deliquoration
Spinal needle replacements20 minutesNumber of needle replacements

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026