Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe University of Texas Medical Branch, Galveston
About this trial
The goal of this clinical trial is to learn if an infusion of lidocaine, with or without steroids, into the middle meningeal artery (MMA) helps relieve severe headaches in patients with spontaneous subarachnoid hemorrhage (SAH). It will also study the safety of this treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Diagnosed with aneurysmal SAH, Hunt and Hess Grades 1-2.
Consent to study procedures and follow-up evaluations.
Disqualifiers
Known allergies to lidocaine or steroids.
Arteriovenous malformations.
Dural Arteriovenous Fistulas.
Other significant intracranial pathologies.
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine
DrugThe participants will receive 50 mg of lidocaine.
Lidocaine and Dexamethasone
DrugThe participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.
Treatment groups
15 Participants
are divided into 3 treatment groupsGroup A: Lidocaine (50 mg bilaterally)Experimental treatment 1 intervention
Group B: Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)Experimental treatment 1 intervention
Group C: No injection (Control group)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.
Time frame
Baseline2
Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.
Time frame
Every 4 hours for 24 hours following the procedureSecondary outcomes
1
Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention
To measure analgetic use by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention. by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention.
Time frame
up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov