Clinical trial NCT06735261: Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage
Official title: Evaluation of the Efficacy of Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage (SAH) After Training of Neurosurgical Intensive Care Nurses.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subarachnoid Hemorrhage in Adult Patients
Keywords: pain
adulte
intensive care
subarachnoid hemorrhage
securing aneurysm
lidocaine
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, randomized, open-label study,
Primary purpose: TREATMENT

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.

Detailed description: Sphenopalatine block is already used for certain types of facial and cranial pain, and could help save morphine consumption during hospitalization. The sphenopalatine ganglion is a crossroads for parasympathetic, sympathetic and sensory pathways. Recently studied in post-puncture dural breaches with promising results, sphenopalatine ganglion block (SPGN) may appear as an interesting alternative therapy in the treatment of SAH headaches. Other advantages of this block are its simplicity, efficacy and the absence of any noticeable adverse effects at the time it is performed. What's more, it is already used routinely in our department, with rapid and effective action. The hypothesis of the trial would be to reduce morphine consumption by at least 50% for patients benefiting from BGSP, for better neurological monitoring and optimal overall pain management in SAH.

Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Demonstrate a 50% change in morphine consumption with sphenopalatine ganglion block during the first 72 hours after cerebral arteriography
timeFrame: during 72 hours
Secondary outcomes:
measure: Demonstrate a significant 3-point change in pain on EN (Simple Numerical Scale)averaged over 7 days after arteriography
timeFrame: during 7 days
measure: Describe morphine consumption per day during the patient's hospitalization for the 2 groups
timeFrame: during hospitalization or 10 days
measure: Describe the complications associated with sphenopalatine ganglion block.
timeFrame: during 7 days
measure: Evaluate the feasibility of the (BGSP) sphenopalatine ganglion block act performed by Ides
timeFrame: during 7 days
measure: Demonstrate that the sphenopalatine ganglion block strategy changes headaches at 28 days.
timeFrame: at 28 days
measure: Demonstrate that the sphenopalatine ganglion block strategy changes patient satisfaction at Day 28
timeFrame: at 28 days
measure: Evaluation of nursing practices on the BGSP technique
timeFrame: up to 28 days
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.