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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат 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. L

Первичные конечные точки

• 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. [Срок оценки: From the beginning of the intervention to the end of following at 7 days]

Вторичные конечные точки (8)

• The proportion of patients considered to be in pain [Срок оценки: At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days]
• Analgesic consumption [Срок оценки: After the initial procedure to the end of following at 7 days]
• The need for rescue therapy [Срок оценки: After the initial procedure to the end of following at 7 days]
• Length of hospital stay [Срок оценки: From enrollment to the end of following at 7 days]
• Headache intensity at different time points [Срок оценки: At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days post-intervention.]
• Occurrence of adverse events [Срок оценки: During the procedure]
• Occurrence of serious adverse events [Срок оценки: From enrollment to the end of following at 7 days]
• Patient satisfaction [Срок оценки: At day 7 post-intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de Clermont-Ferrand — Clermont-Ferrand

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07354464 · RBHP 2025 GUYOT (BRECHE) · 2025-522168-34-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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