NCT Number: NCT06735261
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: during 72 hours
Total morphine consumption in mg in the first 72 hours after cerebral arteriography in the Intensive care (ICU)
Time frame: during 7 days
EN (Simple Numerical Scale) 7-day average
Time frame: during hospitalization or 10 days
Morphine consumption in mg per day during hospitalization.
Time frame: during 7 days
Complications of the sphenopalatine ganglion block technique: incidence of soft palate anesthesia (false liquid routes at H+2), epistaxis, vasovagal reactions, transient hearing loss
Time frame: during 7 days
Number of sphenopalatine ganglion block (BGSP) failures
Time frame: at 28 days
EN (Simple Numerical Scale) at Day 28, consumption of stage 3 analgesics or neuropathic
Time frame: at 28 days
Questionnaire on overall satisfaction with pain management
Time frame: up to 28 days
Satisfaction questionnaire for nurses
Contact information is provided by the study sponsor or research team.
Angélina AP POLLET, RESEARCH NURSE
CONTACT
07476766729 ext. +33
FELIX FP PELEN, Anesthesiologist
CONTACT
04 76 76 67 29 ext. +33
University Hospital, Grenoble
Other
Evaluation of the Efficacy of Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage (SAH) After Training of Neurosurgical Intensive Care Nurses.
Acronym: SATURN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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