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

NCT07354464 | Recruiting Phase 3

• 2 other identifiers: RBHP 2025 GUYOT (BRECHE)2025-522168-34-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

PDPH; Post Dural Puncture Headache

Keywords

Post Dural Puncture Headache; Blood patch; Sphenopalatin ganglion block

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days

• Analgesic consumption

  After the initial procedure to the end of following at 7 days

• The need for rescue therapy

  After the initial procedure to the end of following at 7 days

• Length of hospital stay

  From enrollment to the end of following at 7 days

• Headache intensity at different time points

  At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days post-intervention.

Study Arms (2)

Blood patch

ACTIVE COMPARATOR

Clinicians perform an epidural blood patch following current clinical guidelines.

Drug: Blood patch

Sphenopalatin ganglion block

EXPERIMENTAL

Clinicians perform a sphenopalatin ganglion block following current clinical guidelines.

Drug: Sphenopalatine Ganglion Block

Interventions

Sphenopalatine Ganglion Block DRUG

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.

Sphenopalatin ganglion block

Blood patch DRUG

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.

Blood patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Related Publications (18)

• 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.

  PMID: 30063655 RESULT

• Gayathri 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.

  PMID: 36337388 RESULT

• Dwivedi 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.

  PMID: 37422191 RESULT

• Jespersen 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.

  PMID: 32303377 RESULT

• Kassim 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.

  PMID: 36050945 RESULT

• Puthenveettil 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.

  PMID: 30636799 RESULT

• Cohen 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.

  PMID: 11412202 RESULT

• Nair 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.

  PMID: 28416992 RESULT

• Williams 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.

  PMID: 15321154 RESULT

• Booth 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.

  PMID: 27378709 RESULT

• Safa-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.

  PMID: 11506102 RESULT

• Uppal 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.

  PMID: 37581893 RESULT

• Mims 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.

  PMID: 35358942 RESULT

• Ranganathan 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.

  PMID: 25483233 RESULT

• Heesen 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.

  PMID: 23219220 RESULT

• Moschini V, Marra G, Dabrowska D. Complications of epidural and combined spinal-epidural analgesia in labour. Minerva Anestesiol. 2006 Jan-Feb;72(1-2):47-58.

  PMID: 16407806 RESULT

• Taivainen T, Pitkanen M, Tuominen M, Rosenberg PH. Efficacy of epidural blood patch for postdural puncture headache. Acta Anaesthesiol Scand. 1993 Oct;37(7):702-5. doi: 10.1111/j.1399-6576.1993.tb03793.x.

  PMID: 8249562 RESULT

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 RESULT

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block; Blood Patch, Epidural

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• Adrien Guyot

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 21, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)