Actively Recruiting
Study of Pterygopalatine Fossa Nerve Block Using Ropivacaine and Dexamethasone to Treat Acute Headache After Aneurysmal Subarachnoid Hemorrhage
Led by University of Florida · Updated on 2026-07-06
195
Participants Needed
13
Research Sites
6 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating bilateral pterygopalatine fossa PPF injections using a combination of 20mg ropivacaine and 4mg dexamethasone compared to saline placebo for treating headaches in survivors of aneurysmal subarachnoid hemorrhage SAH. This phase II, multicenter, randomized, double-blinded, placebo-controlled trial uses a sequential parallel comparison design to assess the interventions effects while monitoring intracranial arterial flow using transcranial Doppler TCD during the intervention period. Participants are randomly assigned to one of three groups Group 1 receives active PPF nerve blocks in both stages, Group 2 receives a placebo injection in the first stage followed by an active PPF nerve block in the second stage, and Group 3 receives placebo injections in both stages. The active nerve block consists of 20mg ropivacaine plus 4mg dexamethasone, while placebo injections consist of normal saline. The trial involves two stages of double-blinded treatment over 48 hours. During the study, participants are monitored for efficacy, safety, and tolerability outcomes within 24 to 48 hours after each PPF injection. Researchers assess headache relief and measure intracranial arterial flow velocities using TCD. Participants must be able to communicate their pain scores using an 11-point scale. The study lasts until the primary completion date with ongoing monitoring of treatment responses and adverse effects.
CONDITIONS
Brief Title
BLOCK-SAH - PPF-Block for Post-SAH Headache
Research Team
Y
Yurerkis Montas
R
Ralisa Pop
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