ClinicalTrials.gg
RecruitingNCT07210892Updated Jul 30, 2026

Paramedian Incidence Angles in Spinal Anaesthesia

An observational study in Anesthesia; Adverse Effect, Spinal and Epidural, sponsored by Consorci Sanitari de Terrassa. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Consorci Sanitari de Terrassa · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
90
Sex
All
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Study summary

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.

Read the detailed description

Protractors and visual guides may be used to guide the exact insertion angle according to the skin-to-dural sac distance or depending on the skin-to-transverse process distance when the midline approach is not feasible.

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Conditions studied

  • Anesthesia; Adverse Effect, Spinal and Epidural
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In context

Lead sponsor

Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Any patients requiring spinal anaesthesia

Eligibility criteria

Inclusion Criteria: patients submitted to spinal anaesthesia -

Exclusion Criteria: none

-

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Phase 1. Observational

    Description of usual needle insertion attempts and redirections.

    Other: Measurement of needle insertion angles

Interventions

  • OtherMeasurement of needle insertion angles

    Individualization of needle insertion angle depending on the skin to dural sac distance by means of visual guides and adapted protractors

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What researchers measure

Primary outcomes

  1. Number of needle insertion attempts

    Total number of times that the spinal needle is introduced in the skin

    Time frame: From September 2025 to september 2026.

Secondary outcomes

  1. Number of needle redirections

    Total number of needle redirections in all insertion attempts in a single patient.

    Time frame: From september 2025 to september 2028

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Study locations

1 of 1 sites recruiting
  • APuigdellivolSanchez
    Barcelona, Barcelona 08036, Spain
    Recruiting
    • Anna Puigdellívol-Sánchez, MD, Ph.D. · Contactapuigdellivol@cst.cat · +34 93 5884555
    • Alberto Prats-Galino · Contactaprats@ub.edu · 34 934021900
    • Xavier Sala-Blanch, MD · Principal investigator
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References and documents

Publications

  • 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. PubMed 27598547 ↗
  • Kim Y, Yoo S, Park SK, Bae H, Lim YJ, Kim JT. Optimal angle of needle insertion for spinal anesthesia in patients with spondylolisthesis: an ultrasonographic study. BMC Anesthesiol. 2021 Sep 8;21(1):221. doi: 10.1186/s12871-021-01444-0. PubMed 34496754 ↗
  • Puigdellivol-Sanchez A, Labandeyra H, Prats-Galino A, Sala-Blanch X. The Transverse Process as a Landmark for Estimating Dural Sac Depth and Feasible Planes for Optimized Paramedian Needle Insertions. NeuroSci. 2025 Nov 21;6(4):119. doi: 10.3390/neurosci6040119. PubMed 41283308 ↗
  • 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. PubMed 39728676 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07210892
Lead sponsor
Consorci Sanitari de Terrassa
Collaborators
University of Barcelona, Hospital Clinic of Barcelona
Responsible party
Anna Puigdellívol-Sánchez (Principal investigator. Associate Professor, University of Barcelona) — Principal investigator
First posted
Oct 7, 2025
Start date
Sep 30, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 4, 2028 (estimated)
Last update
Jul 30, 2026

Study contacts

Anna Puigdellívol-Sánchez, M.D., Ph.D.
Contact
apuigdellivol@ub.edu
+34-93-5884555
Alberto Prats-Galino, M.D., Ph.D.
Contact
aprats@ub.edu
+34-93-4021900
Alberto Prats-Galino, M.D., Ph.D
study director · University of Barcelona
Xavier Sala-Blanch, M.D.
study director · Hospital Clinic of Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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