UC Davis Medical Center
Sacramento, California, 95817, United States
Location status: Recruiting
Location contact
Christine Picinich
CONTACT
Christine Picinich, AGACNP-BC, MS
CONTACT
Christine Picinich, AGACNP-BC, MS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06621329
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Phase 2 / Phase 3
Sacramento, California, 95817, United States
Location status: Recruiting
Christine Picinich
CONTACT
Christine Picinich, AGACNP-BC, MS
CONTACT
Christine Picinich, AGACNP-BC, MS
PRINCIPAL_INVESTIGATOR
The study is designed to test the hypothesis that the addition of a transnasal SPG block to standard pain medication is more effective than medication alone in reducing headache associated with acute subarachnoid hemorrhage. It involves 40 participants who meet specific inclusion criteria, such as being over 18 years old, having a secured aneurysm, and the ability to verbalize pain scores. Those with conditions like recent nasal or facial trauma, allergies to specific anesthetics, or pregnancy are excluded.
Participants are randomized into two groups: one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal SPG block. The SPG block is administered using a needleless device called the Tx360, which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways.
Data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the SPG block. The study also includes safety monitoring to track any adverse effects from the intervention. The entire study spans approximately 24 months, with individual participation lasting up to four weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transnasal 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.
Other names: SPG block, peripheral nerve block
Time frame: From enrollment until ICU discharge, up to 14 days
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.
Time frame: From enrollment to hospital discharge, up to 14 days
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.
Time frame: From enrollment to ICU discharge, up to 14 days
Incidence of vasospasm during ICU course will be collected for both arms.
Time frame: From enrollment to hospital discharge, up to 14 days
Adverse reactions or events related to the SPG block procedure will be tracked and documented.
Contact information is provided by the study sponsor or research team.
Janice Wang-Polagruto, PhD, CCRP
CONTACT
Ryan Martin, MD
CONTACT
University of California, Davis
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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