Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage

NCT06735261 | Not Yet Recruiting DMC

• 1 other identifier: CHU GRENOBLE ALPES / SATURN
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Non-traumatic SAH, linked in 85% of cases to the rupture of an intracranial aneurysm, is a serious stroke affecting young people. Half of all survivors suffer cognitive impairment. The presentation is that of a sudden-onset, isolated headache. This population is exposed to headache during hospitalization, which lasts an average of 13 days. This length of hospitalization is due to the fact that these patients must be monitored during the potential vasospasm period that occurs between days 4 and 14 after SAH. The pain associated with SAH is a source of discomfort and increased morphine consumption during the ICU stay, particularly during the first 10 days. Current recommendations call for conventional pain management with a combination of tier 1, 2 and/or 3 analgesics. For headache control, opioids are widely prescribed, sometimes in high doses, with adverse effects, despite efforts to reduce their use. Maximum headache pain scores remain high, indicating inadequate pain management. This highlights the urgent need to study alternative opioid-sparing and analgesia strategies for patients with SAH.

Conditions

Subarachnoid Hemorrhage in Adult Patients

Keywords

pain; adulte; intensive care; subarachnoid hemorrhage; securing aneurysm; lidocaine

Outcome Measures

Primary Outcomes (1)

• Demonstrate a 50% change in morphine consumption with sphenopalatine ganglion block during the first 72 hours after cerebral arteriography

  Total morphine consumption in mg in the first 72 hours after cerebral arteriography in the Intensive care (ICU)

  during 72 hours

Secondary Outcomes (7)

• Demonstrate a significant 3-point change in pain on EN (Simple Numerical Scale)averaged over 7 days after arteriography

  during 7 days

• Describe morphine consumption per day during the patient's hospitalization for the 2 groups

  during hospitalization or 10 days

• Describe the complications associated with sphenopalatine ganglion block.

  during 7 days

• Evaluate the feasibility of the (BGSP) sphenopalatine ganglion block act performed by Ides

  during 7 days

• Demonstrate that the sphenopalatine ganglion block strategy changes headaches at 28 days.

  at 28 days

Study Arms (2)

Control group

NO INTERVENTION

Pain management according to the protocol in force in the neurosurgical intensive care unit (analgesics: Paracetamol, Nefopam and morphine PCA).

Sphenopalatine Ganglion Block using 2% lidocaine

EXPERIMENTAL

Addition of (BGSP) Sphenopalatine ganglion block with Lidocaine 2% Injectable Solution (2mg/ml) 1.5ml \* 3 consecutive times maximum if EN \>3/10, to be repeated every 12h for 7 days if necessary. BGSP performed by the department's Ides after training by the anesthetists.

Interventions

Sphenopalatine Ganglion Block using 2% lidocaine PROCEDURE

A hollow-stem swab soaked in viscous Xylocaine is inserted into the patient's nasal cavity (one swab per nostril) until it stops. 1.5ml Lidocaine 20% (20mg/ml) is injected into each swab using a 5ml syringe and a pink trocar. Both swabs are left in place for 10 min.

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years
• Non-traumatic SAH with or without aneurysm on brain imaging
• WFNS score 1 and 2
• Patient awake and extubated after radiological procedure
• Patient in pain (EN \> 3/10) despite usual level 1 analgesics (Paracetamol + Acupan)
• Affiliated with or benefiting from a social security scheme

You may not qualify if:

• Contraindication to sphenopalatine ganglion block (deviated nasal septum, repeated epistaxis, allergy to Lidocaine)
• Patient unable to assess pain by EN
• Persons covered by Articles L1121-5 to L1121-8 of the CSP and Articles 31 to 35 of Regulation 536/2014.
• Participation in other interventional research
• Patient's refusal to participate
• Arteriography more than 48 hours old
• Inaugural headache lasting more than 48 hours
• Presence of an unsecured vascular malformation at high risk of rupture

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Related Publications (8)

• 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 BACKGROUND

• Hung KC, Chen JY, Ho CN, Sun CK. Use of sphenopalatine ganglion block in patients with postdural puncture headache: a pilot meta-analysis. Br J Anaesth. 2021 Jan;126(1):e25-e27. doi: 10.1016/j.bja.2020.10.005. Epub 2020 Oct 31. No abstract available.

  PMID: 33131755 BACKGROUND

• 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 BACKGROUND

• Viswanathan V, Lucke-Wold B, Jones C, Aiello G, Li Y, Ayala A, Fox WC, Maciel CB, Busl KM. Change in opioid and analgesic use for headaches after aneurysmal subarachnoid hemorrhage over time. Neurochirurgie. 2021 Sep;67(5):427-432. doi: 10.1016/j.neuchi.2021.03.006. Epub 2021 Mar 23.

  PMID: 33771620 BACKGROUND

• Kent S, Mehaffey G. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache in obstetric patients. J Clin Anesth. 2016 Nov;34:194-6. doi: 10.1016/j.jclinane.2016.04.009. Epub 2016 May 11.

  PMID: 27687372 BACKGROUND

• Takmaz SA, Karaoglan M, Baltaci B, Bektas M, Basar H. Transnasal Sphenopalatine Ganglion Block for Management of Postdural Puncture Headache in Non-Obstetric Patients. J Nippon Med Sch. 2021;88(4):291-295. doi: 10.1272/jnms.JNMS.2021_88-406.

  PMID: 34471063 BACKGROUND

• Siegler BH, Dos Santos Pereira RP, Kessler J, Wallwiener S, Wallwiener M, Larmann J, Picardi S, Carr R, Weigand MA, Oehler B. Intranasal Lidocaine Administration via Mucosal Atomization Device: A Simple and Successful Treatment for Postdural Puncture Headache in Obstetric Patients. Biomedicines. 2023 Dec 13;11(12):3296. doi: 10.3390/biomedicines11123296.

  PMID: 38137518 BACKGROUND

• Singh S, Iqbal J, Jahan N, Yadav R. Sphenopalatine Ganglion Block for the Treatment of Severe Headache following a Ruptured Aneurysm. Neurol India. 2022 Nov-Dec;70(6):2452-2453. doi: 10.4103/0028-3886.364060. No abstract available.

  PMID: 36537435 BACKGROUND

Related Links

• Lidocaine Toxicity

MeSH Terms

Conditions

Pain; Subarachnoid Hemorrhage

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

FELIX FP PELEN, Anesthesiologist

CONTACT

04 76 76 67 29; pfpelen@chu-grenoble.fr

Angélina AP POLLET, RESEARCH NURSE

CONTACT

07476766729; apollet@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, randomized, open-label study,

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 16, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share