PDPHPhase 3BRECHENCT07354464
Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
A Phase 3 study testing Sphenopalatine Ganglion Block and Blood patch in people with PDPH and Post Dural Puncture Headache, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PDPH, Post Dural Puncture Headache
- What is being tested?
- Sphenopalatine Ganglion Block and Blood patch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2026to Feb 2028
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.),
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Adrien Guyot
About this study
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.
Read more
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.
Read the 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.
- Conditions
- PDPH, Post Dural Puncture Headache
- Being tested
- Sphenopalatine Ganglion Block, Blood patch
- Keywords
- Post Dural Puncture Headache, Blood patch, Sphenopalatin ganglion block
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion BlockDrug
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.
Blood patchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood patch | Active comparator | Clinicians perform an epidural blood patch following current clinical guidelines. Receives: Drug: Blood patch |
| Sphenopalatin ganglion block | Experimental | Clinicians perform a sphenopalatin ganglion block following current clinical guidelines. Receives: Drug: Sphenopalatine Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: From the beginning of the intervention to the end of following at 7 days
Secondary outcomes (8)
The proportion of patients considered to be in pain
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)]
Measured: At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days
Analgesic consumption
Analgesic consumption (paracetamol, nefopam, NSAIDs, opioids) in milligrams after the procedure
Measured: After the initial procedure to the end of following at 7 days
The need for rescue therapy
Need for rescue treatment with an epidural blood patch after the initial procedure
Measured: After the initial procedure to the end of following at 7 days
Length of hospital stay
Measured: From enrollment to the end of following at 7 days
Headache intensity at different time points
Headache intensity is evaluated using a numerical rating scale [ranging from 0 (no pain) to 10 (the worst pain ever)]
Measured: At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days post-intervention.
Occurrence of adverse events
Measured: During the procedure
Occurrence of serious adverse events
Measured: From enrollment to the end of following at 7 days
Patient satisfaction
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.
Measured: At day 7 post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start19 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PDPHStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien Guyot, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354464
- Sponsor's protocol ID
- RBHP 2025 GUYOT (BRECHE)
- Other IDs
- 2025-522168-34-00, 2025
- Acronym
- BRECHE
- Status last verified
- Nov 2025
- First submitted
- 7 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen S, Levin D, Mellender S, Zhao R, Patel P, Grubb W, Kiss G. Topical Sphenopalatine Ganglion Block Compared With Epidural Blood Patch for Postdural Puncture Headache Management in Postpartum Patients: A Retrospective Review. Reg Anesth Pain Med. 2018 Nov;43(8):880-884. doi: 10.1097/AAP.0000000000000840.
PubMed 30063655Gayathri GA, Karthik K, Saravanan R, Meshach MD, Pushparani A. A randomized control study to assess the efficacy of the sphenopalatine ganglion block in patients with post dural puncture headache. Saudi J Anaesth. 2022 Oct-Dec;16(4):401-405. doi: 10.4103/sja.sja_780_21. Epub 2022 Sep 3.
PubMed 36337388Dwivedi P, Singh P, Patel TK, Bajpai V, Kabi A, Singh Y, Sharma S, Kishore S. Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials. Braz J Anesthesiol. 2023 Nov-Dec;73(6):782-793. doi: 10.1016/j.bjane.2023.06.002. Epub 2023 Jul 6.
PubMed 37422191Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.
PubMed 32303377Kassim Z, Kamar RM, Zakariah MF, Chui Geok IS. Transnasal sphenopalatine ganglion block for postdural puncture headache in obstetric patients: A Malaysian experience report. J Taibah Univ Med Sci. 2022 Feb 25;17(5):805-809. doi: 10.1016/j.jtumed.2022.02.008. eCollection 2022 Oct.
PubMed 36050945Puthenveettil N, Rajan S, Mohan A, Paul J, Kumar L. Sphenopalatine ganglion block for treatment of post-dural puncture headache in obstetric patients: An observational study. Indian J Anaesth. 2018 Dec;62(12):972-977. doi: 10.4103/ija.IJA_443_18.
PubMed 30636799Cohen S, Trnovski S, Zada Y. A new interest in an old remedy for headache and backache for our obstetric patients: a sphenopalatine ganglion block. Anaesthesia. 2001 Jun;56(6):606-7. No abstract available.
PubMed 11412202Nair AS, Rayani BK. Sphenopalatine ganglion block for relieving postdural puncture headache: technique and mechanism of action of block with a narrative review of efficacy. Korean J Pain. 2017 Apr;30(2):93-97. doi: 10.3344/kjp.2017.30.2.93. Epub 2017 Mar 31.
PubMed 28416992Williams EJ, Beaulieu P, Fawcett WJ, Jenkins JG. Efficacy of epidural blood patch in the obstetric population. Int J Obstet Anesth. 1999 Apr;8(2):105-9. doi: 10.1016/s0959-289x(99)80007-7.
PubMed 15321154Booth JL, Pan PH, Thomas JA, Harris LC, D'Angelo R. A retrospective review of an epidural blood patch database: the incidence of epidural blood patch associated with obstetric neuraxial anesthetic techniques and the effect of blood volume on efficacy. Int J Obstet Anesth. 2017 Feb;29:10-17. doi: 10.1016/j.ijoa.2016.05.007. Epub 2016 Jun 3.
PubMed 27378709Safa-Tisseront V, Thormann F, Malassine P, Henry M, Riou B, Coriat P, Seebacher J. Effectiveness of epidural blood patch in the management of post-dural puncture headache. Anesthesiology. 2001 Aug;95(2):334-9. doi: 10.1097/00000542-200108000-00012.
PubMed 11506102Uppal V, Russell R, Sondekoppam R, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo CA, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Consensus Practice Guidelines on Postdural Puncture Headache From a Multisociety, International Working Group: A Summary Report. JAMA Netw Open. 2023 Aug 1;6(8):e2325387. doi: 10.1001/jamanetworkopen.2023.25387.
PubMed 37581893Mims SC, Tan HS, Sun K, Pham T, Rubright S, Kaplan SJ, Habib AS. Long-term morbidities following unintentional dural puncture in obstetric patients: A systematic review and meta-analysis. J Clin Anesth. 2022 Aug;79:110787. doi: 10.1016/j.jclinane.2022.110787. Epub 2022 Mar 28.
PubMed 35358942Ranganathan P, Golfeiz C, Phelps AL, Singh S, Shnol H, Paul N, Attaallah AF, Vallejo MC. Chronic headache and backache are long-term sequelae of unintentional dural puncture in the obstetric population. J Clin Anesth. 2015 May;27(3):201-6. doi: 10.1016/j.jclinane.2014.07.008. Epub 2014 Dec 4.
PubMed 25483233Heesen M, Klohr S, Rossaint R, Walters M, Straube S, van de Velde M. Insertion of an intrathecal catheter following accidental dural puncture: a meta-analysis. Int J Obstet Anesth. 2013 Jan;22(1):26-30. doi: 10.1016/j.ijoa.2012.10.004. Epub 2012 Dec 5.
PubMed 23219220
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sphenopalatine Block Compared to Blood Patch in the Management of Post-dural Puncture Headaches
- ClinicalTrials.gov ID
- NCT07354464
- Acronym / sponsor ID
- BRECHE / RBHP 2025 GUYOT (BRECHE)
- Conditions
- PDPH, Post Dural Puncture Headache
- Keywords
- Post Dural Puncture Headache, Blood patch, Sphenopalatin ganglion block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood patch | Active comparator | Drug: Blood patchClinicians perform an epidural blood patch following current clinical guidelines. |
| Sphenopalatin ganglion block | Experimental | Drug: Sphenopalatine Ganglion BlockClinicians perform a sphenopalatin ganglion block following current clinical guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.),
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 |
|---|---|---|
| Sphenopalatine Ganglion BlockThe 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. | Drug | Sphenopalatin ganglion block |
| Blood patchThe 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. | Drug | Blood patch |
Primary outcome
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.
8 secondary outcomes
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
Analgesic consumption
Time frame: 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
Length of hospital stay
Time frame: 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.
Occurrence of adverse events
Time frame: During the procedure
Occurrence of serious adverse events
Time frame: From enrollment to the end of following at 7 days
Patient satisfaction
Time frame: At day 7 post-intervention.
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 27 Feb 2026.
- Results publication: PubMed 30063655Cohen S, Levin D, Mellender S, Zhao R, Patel P, Grubb W, Kiss G. Topical Sphenopalatine Ganglion Block Compared With Epidural Blood Patch for Postdural Puncture Headache Management in Postpartum Patients: A Retrospective Review. Reg Anesth Pain Med. 2018 Nov;43(8):880-884. doi: 10.1097/AAP.0000000000000840.
- Results publication: PubMed 36337388Gayathri GA, Karthik K, Saravanan R, Meshach MD, Pushparani A. A randomized control study to assess the efficacy of the sphenopalatine ganglion block in patients with post dural puncture headache. Saudi J Anaesth. 2022 Oct-Dec;16(4):401-405. doi: 10.4103/sja.sja_780_21. Epub 2022 Sep 3.
- Results publication: PubMed 37422191Dwivedi P, Singh P, Patel TK, Bajpai V, Kabi A, Singh Y, Sharma S, Kishore S. Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials. Braz J Anesthesiol. 2023 Nov-Dec;73(6):782-793. doi: 10.1016/j.bjane.2023.06.002. Epub 2023 Jul 6.
- Results publication: PubMed 32303377Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.
- Results publication: PubMed 36050945Kassim Z, Kamar RM, Zakariah MF, Chui Geok IS. Transnasal sphenopalatine ganglion block for postdural puncture headache in obstetric patients: A Malaysian experience report. J Taibah Univ Med Sci. 2022 Feb 25;17(5):805-809. doi: 10.1016/j.jtumed.2022.02.008. eCollection 2022 Oct.
- Results publication: PubMed 30636799Puthenveettil N, Rajan S, Mohan A, Paul J, Kumar L. Sphenopalatine ganglion block for treatment of post-dural puncture headache in obstetric patients: An observational study. Indian J Anaesth. 2018 Dec;62(12):972-977. doi: 10.4103/ija.IJA_443_18.
- Results publication: PubMed 11412202Cohen S, Trnovski S, Zada Y. A new interest in an old remedy for headache and backache for our obstetric patients: a sphenopalatine ganglion block. Anaesthesia. 2001 Jun;56(6):606-7. No abstract available.
- Results publication: PubMed 28416992Nair AS, Rayani BK. Sphenopalatine ganglion block for relieving postdural puncture headache: technique and mechanism of action of block with a narrative review of efficacy. Korean J Pain. 2017 Apr;30(2):93-97. doi: 10.3344/kjp.2017.30.2.93. Epub 2017 Mar 31.
- Results publication: PubMed 15321154Williams EJ, Beaulieu P, Fawcett WJ, Jenkins JG. Efficacy of epidural blood patch in the obstetric population. Int J Obstet Anesth. 1999 Apr;8(2):105-9. doi: 10.1016/s0959-289x(99)80007-7.
- Results publication: PubMed 27378709Booth JL, Pan PH, Thomas JA, Harris LC, D'Angelo R. A retrospective review of an epidural blood patch database: the incidence of epidural blood patch associated with obstetric neuraxial anesthetic techniques and the effect of blood volume on efficacy. Int J Obstet Anesth. 2017 Feb;29:10-17. doi: 10.1016/j.ijoa.2016.05.007. Epub 2016 Jun 3.
- Results publication: PubMed 11506102Safa-Tisseront V, Thormann F, Malassine P, Henry M, Riou B, Coriat P, Seebacher J. Effectiveness of epidural blood patch in the management of post-dural puncture headache. Anesthesiology. 2001 Aug;95(2):334-9. doi: 10.1097/00000542-200108000-00012.
- Results publication: PubMed 37581893Uppal V, Russell R, Sondekoppam R, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo CA, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Consensus Practice Guidelines on Postdural Puncture Headache From a Multisociety, International Working Group: A Summary Report. JAMA Netw Open. 2023 Aug 1;6(8):e2325387. doi: 10.1001/jamanetworkopen.2023.25387.
- Individual participant dataSharing planned: No
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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.
Adrien Guyot principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sphenopalatine Ganglion Block and Blood patch in people with PDPH and Post Dural Puncture Headache, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 inclusion and 10 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 27 Feb 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT07354464, which also lists 18 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 27 Feb 2026.