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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522168-34-00 | EU Trial (CTIS) Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood patch | Active Comparator | Clinicians perform an epidural blood patch following current clinical guidelines. |
|
| Sphenopalatin ganglion block | Experimental | Clinicians perform a sphenopalatin ganglion block following current clinical guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 0473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Adrien Guyot | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30063655 | Result | 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. | |
| 36337388 | Result |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D017217 | Blood Patch, Epidural |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
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|
| 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. |
|
| Analgesic consumption |
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 | 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 | 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)] | At 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, 48 hours, and 7 days post-intervention. |
| Occurrence of adverse events | During the procedure |
| Occurrence of serious adverse events | 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:
| At day 7 post-intervention. |
| 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. |
| 37422191 | 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. |
| 32303377 | 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. |
| 36050945 | 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. |
| 30636799 | 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. |
| 11412202 | 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. |
| 28416992 | 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. |
| 15321154 | 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. |
| 27378709 | 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. |
| 11506102 | 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. |
| 37581893 | 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. |
| 35358942 | 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. |
| 25483233 | 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. |
| 23219220 | 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. |
| 16407806 | 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. |
| 8249562 | 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. |
| 29368949 | 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. |
| D009422 | Nervous System Diseases |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007268 | Injections, Epidural |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |