Efficacy of sphenopalatine block compared to blood patch in the management of post-dural puncture syndrome.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

19 Feb 2026 → ongoing

Decision date (initial)

2025-11-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Evaluate the effectiveness of the sphenopalatine block for the management of post-dural puncture headaches compared to the current standard treatment, the blood patch, within 7 days.

Secondary objectives 7

1. Compare the consumption of analgesics of patients treated with the sphenopalatine block technique versus the current standard treatment, the blood patch.
2. Compare the need to resort to a remedy treatment for patients treated with the sphenopalatine block technique versus the current standard treatment, the blood patch.
3. Compare the duration of hospitalization of patients treated with the sphenopalatine block technique versus the current standard treatment, the blood patch.
4. Compare the intensity of headaches at different times of patients treated with the sphenopalatine block technique versus the current standard treatment, the blood patch.
5. Compare the occurrence of adverse events during the performance of the procedure between the sphenopalatine block technique versus the current standard treatment, the blood patch.
6. Compare the occurrence of serious adverse events between patients treated with the sphenopalatine block technique versus those treated with the current standard treatment, the blood patch.
7. Compare satisfaction of patients treated with the sphenopalatine block technique versus those treated with the current standard treatment, the blood patch.

Conditions and MedDRA coding

Post-dural puncture syndrome

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Presence of post-dural-puncture headaches meeting the criteria of the International Classification of Headache Disorders (ICHD-3)
2. Present persistent headaches after 24 hours of conservative treatment.
3. Patients older than 18 years
4. Patients who have given their informed consent
5. Patients affiliated with a Social Security scheme.

Exclusion criteria 8

1. Patients under protection measures (guardianship or curatorship) or deprived of liberty (prisoners)
2. Pregnant patients
3. Patients presenting an allergy to one of the medications used in the protocol
4. Patients presenting with a clinical picture of atypical post-dural puncture headache that may suggest a post-puncture complication (consciousness disorder, focal neurological deficit, epilepsy, visual disturbance...)
5. Patients presenting with chronic headaches requiring preventive treatment
6. Patients with a history of spine surgery preventing the realization of the blood patch
7. Patients with a contraindication for the blood patch procedure (local or systemic infection, platelets < 80 G/L, coagulation disorder, progressive neurological disease)
8. Patients with a contraindication for performing the sphenopalatine block (nasal polyps, rhinopharyngitis, deviation of the nasal septum).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Evolution of headache intensity in the upright position assessed using a numerical verbal scale (NVS) from 0 (no pain) to 10 (the most intense pain possible) at the beginning of the intervention, at 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days after the performance of the sphenopalatine block or blood patch.

Secondary endpoints 7

1. The consumption of analgesics (Acétaminophen, Nefopam, NSAIDs, morphine) in milligrams after the procedure and for 7 days.
2. The need for a rescue treatment with a blood patch after the first procedure
3. The duration of hospitalization during the 7 days post-intervention
4. The intensity of headaches at 30 minutes, at 1 hour, at 2 hours, at 6 hours, at 24 hours, at 48 hours, and at 7 days.
5. The undesirable events during the performance of the procedure
6. Serious adverse events (radicular compression, meningitis, cauda equina syndrome...),
7. Patient satisfaction assessed at 7 days after treatment using a 5-item Likert scale

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont-Ferrand

Postcode

63000

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications