Paramedian Incidence Angles in Spinal Anaesthesia.

NCT ID: NCT07210892

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-09-04

Brief Summary

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The objective here is to quantify the number of punctures and redirections during routine practice in the anesthesiology department, verify the final angle of incidence and the sac-skin distance by ultrasound, and determine the optimal, maximum, and minimum angles that would have allowed successful punctures. The objective is also to correlate ultrasound and plain X-ray distances, if available. These angles would then be inferred in advance in patients who must undergo spinal anesthesia, assessing whether this prior estimate reduces the number of punctures and redirections.

Detailed Description

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Conditions

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Patients Submitted to Spinal Anaesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase 1. Observational

Description of usual needle insertion attempts and redirections.

Measurement of needle insertion angles

Intervention Type OTHER

Individualization of needle insertion angle depending on the skin to dural sac distance

Interventions

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Measurement of needle insertion angles

Individualization of needle insertion angle depending on the skin to dural sac distance

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Anna Puigdellívol-Sánchez

Dr Anna Puigdellívol Sánchez

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Prats-Galino, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

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APuigdellivolSanchez

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Anna Puigdellívol-Sánchez, M.D., Ph.D.

Role: CONTACT

+34-93-5884555

Alberto Prats-Galino, M.D., Ph.D.

Role: CONTACT

+34-93-4021900

Facility Contacts

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Anna Puigdellívol-Sánchez

Role: primary

935884555

Alberto Prats-Galino

Role: backup

934021900

References

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Puigdellivol-Sanchez A, Reina MA, Sala-Blanch X, Pomes-Tallo J, Prats-Galino A. Pythagoras and Cosines: The skin-dural sac distance and optimal angles in paramedian spinal anesthesia. Clin Anat. 2016 Nov;29(8):1046-1052. doi: 10.1002/ca.22792. Epub 2016 Oct 6.

Reference Type BACKGROUND
PMID: 27598547 (View on PubMed)

Labandeyra H, Sala-Blanch X, Prats-Galino A, Puigdellivol-Sanchez A. Neuraxial Anesthesia and Risk of Root Damage: A 3D Ex Vivo Study. NeuroSci. 2024 Dec 3;5(4):623-634. doi: 10.3390/neurosci5040044.

Reference Type RESULT
PMID: 39728676 (View on PubMed)

Other Identifiers

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HCB/2018/1236

Identifier Type: -

Identifier Source: org_study_id

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