Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches (BRECHE)

February 26, 2026 updated by: University Hospital, Clermont-Ferrand

Post-dural puncture headache (PDPH) is an iatrogenic complication following a dural puncture, which may occur after lumbar puncture, spinal or epidural anesthesia. These headaches are defined as positional headaches, which worsen in the upright position and improve in the supine position, occurring within 5 days after a dural puncture.

PDPH is disabling, particularly in the postpartum period and is often associated with symptoms such as nausea, vomiting, neck stiffness, photophobia, and hearing loss. While serious immediate complications (e.g., subdural hematoma, cerebral venous thrombosis) are rare, long-term consequences - including chronic headaches, neck or low back pain and depression, have been described.

A conservative treatment is usually started during the first 24 hours, but it often proves insufficient, leading to the use of an additional epidural blood patch therapy. While considered as the gold standard, this procedure is invasive and presents limitations. The effectiveness of the epidural blood patch is variable (33-91 %), and the need for a second blood patch is not uncommon. The risks associated with the procedure include second dural puncture, low back pain, vasovagal syncope and paresthesia. Serious complications could occur with reported cases of aseptic meningitis or acute subdural hematoma.

An emerging alternative is the sphenopalatine ganglion block that is a less invasive procedure showing promising results. Several recent trials suggested the safety, feasibilty and efficacy of this intervention with excellent tolerance. Then, we aim to compare the efficacy and safety of these procedures in a randomized controlled trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center interventional study classified as a clinical drug trial (European Regulation n°536-2014).

Patients suffering from post-dural puncture headache resistant to medical treatment for 24 hours are refered by the treating physician to the referent anesthesia team for consultation.

Patient screening for the study is realised and study information is delivered by the anesthesia team. After the verification of inclusion and non-inclusion criteria, inform consent is searched. The patient is managed either with an epidural blood patch or a sphenopalatine ganglion block, depending on the group of randomisation. During at least 30 minutes post-intervention, patients are monitored in the post-anesthesia care unit.

Headache intensity is assessed using the numerical rating scale just before the intervention and at 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours and 7 days post-intervention. All secondary outcomes are evaluated during the 7 days after the intervention. This assessment is carried out by a clinical research associate blinded to the treatment allocation.

The patient will be hospitalized for at least 6 hours and if the treatment is ineffective after 24 hours, a rescue therapy with an epidural blood patch will be mandated, regardless of the patient's randomization group. If the patient is discharged within 7 days follow up the intervention, the numerical rating scale and secondary outcomes assessments will be conducted by telephone.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with post-dural puncture headache meeting the criteria of the International Classification of Headache Disorders (ICHD-3) and persisting after 24 hours of conservative treatment,
  • Patients aged over 18 years,
  • Patients affiliated to a social security health insurance system,
  • Patients who have provided written informed consent.

Exclusion Criteria:

  • Patients under legal protection (guardianship or curatorship), deprived of liberty (prisoners), or under judicial safeguard,
  • Pregnant patients,
  • Patients with hypersensitivity to lidocaine, prilocaine, local anesthetics of the amide type, or to any of the excipients listed in the composition of the drugs used in the protocol,
  • Patients with acute porphyria, atrioventricular conduction disorders requiring permanent cardiac pacing not yet implemented, or epilepsy not controlled by treatment,
  • Patients receiving antiarrhythmic therapy associated with torsades de pointes (amiodarone, disopyramide, quinidine derivatives, sotalol, etc.),
  • Patients with atypical post-dural puncture headache suggestive of a post-dural puncture complication (altered consciousness, focal neurological deficit, seizures, visual disturbances, etc.),
  • Patients with chronic headaches requiring preventive treatment,
  • Patients with a history of spinal surgery precluding the performance of an epidural blood patch,
  • Patients with contraindications to epidural blood patch (local or systemic infection, platelet count < 80 G/L, coagulation disorders, progressive neurological disease),
  • Patients with contraindications to sphenopalatine ganglion block (nasal polyposis, rhinopharyngitis, deviated nasal septum).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blood patch
Clinicians perform an epidural blood patch following current clinical guidelines.
Drug: Blood patch
The epidural blood patch is performed in the post-anesthesia care unit (PACU). The patient is continuously monitored, with measurement of oxygen saturation, heart rate, and arterial blood pressure. The patient is seated at the edge of the bed, with the anesthesiologist positioned behind the patient. The procedure is carried out in strict adherence to aseptic techniques. The puncture is ideally performed at the L3-L4 or L4-L5 interspace, preferably at or below the level of the initial puncture. Local anesthesia is achieved using 1% injectable lidocaine at the puncture site. The epidural space is identified using the loss-of-resistance technique with saline. Once the epidural space has been identified, peripheral venous blood is collected and slowly injected into the epidural space until the patient reports a sensation of pressure or lumbar pain, with a maximum volume of 30 mL. The patient is then placed in the strict supine position and monitored for at least 30 minutes in the PACU.
Experimental: Sphenopalatin ganglion block
Clinicians perform a sphenopalatin ganglion block following current clinical guidelines.
Drug: Sphenopalatine Ganglion Block
The sphenopalatine ganglion block is performed in the post-anesthesia care unit (PACU). The patient is continuously monitored, including measurement of oxygen saturation, heart rate, and arterial blood pressure. The patient is placed in the supine position with the head extended. The anesthesiologist inserts a cotton-tipped applicator (sterile microbiology swab) soaked with 2.5% lidocaine cream into each nasal cavity until bony contact is reached. Subsequently, 1 mL of 5% injectable lidocaine is administered into each nasal cavity. The cotton-tipped applicators are left in place for 10 minutes and then removed. If headache persists upon patient mobilization to the upright position, the sphenopalatine ganglion block may be repeated a second time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main objective of our study is to evaluate the efficacy of the sphenopalatine ganglion block in the management of post-dural puncture headache compared to the epidural blood patch.
Time Frame: From the beginning of the intervention to the end of following at 7 days
The primary outcome measure is the evolution of headache intensity in standing position, evaluated using a numerical rating scale [ranging from 0 (no pain) to 10 (the worst pain ever)] 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 a sphenopalatine ganglion block or an epidural blood patch.
From the beginning of the intervention to the end of following at 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients considered to be in pain
Time Frame: At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days
Proportion of patients experiencing pain according to thresholds commonly reported in the literature and evaluated using a numerical rating scale [ranging from 0 (no pain) to 10 (the worst pain ever)]
At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days
Analgesic consumption
Time Frame: After the initial procedure to the end of following at 7 days
Analgesic consumption (paracetamol, nefopam, NSAIDs, opioids) in milligrams after the procedure
After the initial procedure to the end of following at 7 days
The need for rescue therapy
Time Frame: After the initial procedure to the end of following at 7 days
Need for rescue treatment with an epidural blood patch after the initial procedure
After the initial procedure to the end of following at 7 days
Length of hospital stay
Time Frame: From enrollment to the end of following at 7 days
From enrollment to the end of following at 7 days
Headache intensity at different time points
Time Frame: At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days post-intervention.
Headache intensity is evaluated using a numerical rating scale [ranging from 0 (no pain) to 10 (the worst pain ever)]
At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days post-intervention.
Occurrence of adverse events
Time Frame: During the procedure
During the procedure
Occurrence of serious adverse events
Time Frame: From enrollment to the end of following at 7 days
From enrollment to the end of following at 7 days
Patient satisfaction
Time Frame: At day 7 post-intervention.

Patient satisfaction assessed 7 days after treatment using a 5-item Likert scale.

The Likert scale is a 5-point forced-choice scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). It is a widely used ordinal psychometric tool that assesses the degree of agreement or disagreement of respondents with a series of items. In this study, the following items were used:

  • The procedure (epidural blood patch or sphenopalatine ganglion block) was an unpleasant/painful experience.
  • The procedure (epidural blood patch or sphenopalatine ganglion block) effectively relieved my headache.
  • The procedure (epidural blood patch or sphenopalatine ganglion block) provided rapid relief of my headache.
  • At present, I no longer experience any symptoms of post-dural puncture headache.
At day 7 post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Adrien Guyot, CHU de Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2025 GUYOT (BRECHE)
  • 2025-522168-34-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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