Paramedian Incidence Angles in Spinal Anaesthesia

NCT07210892 | Recruiting

• 1 other identifier: HCB/2018/1236
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Outcome Measures

Primary Outcomes (1)

• Number of needle insertion attempts

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

  From September 2025 to september 2026.

Secondary Outcomes (1)

• Number of needle redirections

  From september 2025 to september 2028

Study Arms (1)

Phase 1. Observational

Description of usual needle insertion attempts and redirections.

Other: Measurement of needle insertion angles

Interventions

Measurement of needle insertion angles OTHER

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

Phase 1. Observational

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patients requiring spinal anaesthesia

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• University of Barcelona: collaborator

Study Sites (1)

APuigdellivolSanchez

Barcelona, 08036, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 27598547 BACKGROUND

• 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.

  PMID: 34496754 BACKGROUND

• 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.

  PMID: 41283308 RESULT

• 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.

  PMID: 39728676 RESULT

Study Officials

• Alberto Prats-Galino, M.D., Ph.D

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+34-93-5884555; apuigdellivol@ub.edu

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

CONTACT

+34-93-4021900; aprats@ub.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. Associate Professor

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 4, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)