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Numbing spray in the nose may ease severe headaches after spinal tap mishap

NCT ID NCT07494383

Symptom relief Sponsor: ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a simple procedure called a sphenopalatine ganglion block (SPGB) — applying numbing medicine (lidocaine) inside the nose — against standard care (bed rest and extra fluids) for people who developed a severe headache after an accidental spinal needle puncture. Twenty-six adults took part. The main goal was to see if the study design was practical, not yet to prove the treatment works. Results will help plan a larger trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lidocaine (nasal spray)
What this could lead to
If this approach works, it could offer a quick, non-surgical way to relieve severe headaches after accidental spinal needle puncture.
What could go wrong
This is a very small pilot study (26 people) testing feasibility, not effectiveness. The nerve block may not work better than simple bed rest and fluids, and it carries rare risks like nosebleed or allergic reaction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

26 people

The number who actually took part.

Started

May 2024

Finished

Jun 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-55 years * ASA physical status I or II * Developed post-dural puncture headache following accidental dural puncture with a 17G Tuohy needle during an epidural procedure * Enrolled within 24 hours of dural puncture * PDPH diagnosed clinically as headache with postural characteristics (worsening upright, relief supine), consistent with ICHD criteria * Willing to provide written informed consent Exclusion Criteria: * History of migraine or chronic headache * Received prior intervention for PDPH before enrolment * Chronic use of anticonvulsants, gabapentinoids, or weak opioids Elimination Criteria: * Patient withdrawal of consent at any point during the study * Development of side effects requiring further interventional management

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Conditions

The condition(s) this trial relates to.

Headache headache disorder intracranial hypotension Post-Dural Puncture Headache

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Headache Post-dural puncture headache

Contacts and locations

Locations

  • Hospital Regional "General Ignacio Zaragoza," ISSSTE

    Mexico City, Mexico City, 09360, Mexico

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