Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of California, Davis

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Transnasal sphenopalatine ganglion block

    Combination product

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard of Care Medications for HeadacheNo intervention 0 interventions
Group B: Transnasal SPG Block and Standard of Care MedicationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment until ICU discharge, up to 14 days

Secondary outcomes

1

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.

Time frame
From enrollment to hospital discharge, up to 14 days

Other outcomes

1

Vasospasm

Incidence of vasospasm during ICU course will be collected for both arms.

Time frame
From enrollment to ICU discharge, up to 14 days
2

Incidence of adverse events related to SPG block procedure

Adverse reactions or events related to the SPG block procedure will be tracked and documented.

Time frame
From enrollment to hospital discharge, up to 14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Agnes Marshall Walker Foundation

Collaborator