Anesthesia; Adverse Effect, Spinal and EpiduralNCT07210892
Paramedian Incidence Angles in Spinal Anaesthesia
An observational study of Anesthesia; Adverse Effect, Spinal and Epidural, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Adverse Effect, Spinal and Epidural
- What is being tested?
- Measurement of needle insertion angles
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2025to 4 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any patients requiring spinal anaesthesia
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
APuigdellivolSanchez
Barcelona, Barcelona, 08036
Anna Puigdellívol-Sánchez, MD, Ph.D., +34 93 5884555, apuigdellivol@cst.cat
Alberto Prats-Galino, 34 934021900, aprats@ub.edu
About this study
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.
- Being tested
- Measurement of needle insertion angles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of needle insertion anglesOther
Individualization of needle insertion angle depending on the skin to dural sac distance by means of visual guides and adapted protractors
| Study group | Role | What they receive |
|---|---|---|
| Phase 1. Observational | Description of usual needle insertion attempts and redirections. Receives: Other: Measurement of needle insertion angles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of needle insertion attempts
Total number of times that the spinal needle is introduced in the skin
Measured: 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.
Measured: From september 2025 to september 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start30 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion4 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse Effect, Spinal and EpiduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Anna Puigdellívol-Sánchez, University of Barcelona
- Investigators
- Alberto Prats-Galino, M.D., Ph.D, Study director, University of BarcelonaXavier Sala-Blanch, M.D., Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210892
- Sponsor's protocol ID
- HCB/2018/1236
- Status last verified
- Jul 2026
- First submitted
- 30 Sep 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27598547Kim 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 34496754Puigdellivol-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 41283308Labandeyra 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paramedian Incidence Angles in Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT07210892
- Acronym / sponsor ID
- HCB/2018/1236
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- University of Barcelona, Hospital Clinic of Barcelona
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 4 Sep 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1. Observational | – | Other: Measurement of needle insertion anglesDescription of usual needle insertion attempts and redirections. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients requiring spinal anaesthesia
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of needle insertion anglesIndividualization of needle insertion angle depending on the skin to dural sac distance by means of visual guides and adapted protractors | Other | Phase 1. Observational |
Primary outcome
Number of needle insertion attempts
Time frame: From September 2025 to september 2026.
Total number of times that the spinal needle is introduced in the skin
1 secondary outcome
Number of needle redirections
Time frame: From september 2025 to september 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 27598547Puigdellivol-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.
- Background: PubMed 34496754Kim 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.
- Results publication: PubMed 41283308Puigdellivol-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.
- Results publication: PubMed 39728676Labandeyra 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberto Prats-Galino, M.D., Ph.D study director
University of Barcelona
Xavier Sala-Blanch, M.D. study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Adverse Effect, Spinal and Epidural, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Puigdellívol-Sánchez, M.D., Ph.D. (+34-93-5884555, apuigdellivol@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of needle insertion attempts (time frame: From September 2025 to september 2026.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210892, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.