About this trial
The study titled \"Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\" is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion (SPG) block in addition to standard pain medication for reducing headache severity in patients with acute subarachnoid hemorrhage (aSAH). The study also examines whether this intervention can reduce opioid requirements during hospitalization and upon discharge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute subarachnoid hemorrhage
Age greater than 18 years
Secured aneurysm
Patient can verbalize pain score to clinician, nurse, medical translator, or surrogate decision
Disqualifiers
Less than 18 years old
Unsecured aneurysm
Pregnant or lactating
Prisoner
Trial design
Parallel
Treatments tested in this trial
Transnasal sphenopalatine ganglion block
Combination productTransnasal sphenopalatine ganglion blocks will be performed using the Tx360 device. Medications used during the procedure include 0.75% bupivacaine with or without 1 mg of preservative free dexamethasone.
Treatment groups
Trial outcomes
Primary outcomes
Numerical pain rating scale
Pain scores will be obtained at regular intervals to compare pain control between the two arms. Pain scores will be collected multiple times throughout each ICU day, up to ICU day 14.
Secondary outcomes
Morphine milligram equivalents (MME)
Total Morphine milligram equivalents per ICU day will be collected for up to 14 days. Total morphine milligram equivalents will also be collected on the day of hospital discharge. Total morphine milligram equivalents for ICU course and total morphine milligram equivalents on day of discharge will be compared between the two arms.
Other outcomes
Vasospasm
Incidence of vasospasm during ICU course will be collected for both arms.
Incidence of adverse events related to SPG block procedure
Adverse reactions or events related to the SPG block procedure will be tracked and documented.
Sponsors and contacts
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University of California, Davis
Lead sponsor
Agnes Marshall Walker Foundation
Collaborator