A Randomized, Dose-Finding Study of Sphenopalatine Ganglion Block With Bupivacaine for Emergency Department Patients With Headache
Abstract
Study objective: To determine, when performing a sphenopalatine ganglion block (SPGB) for emergency department (ED) patients with headache, whether larger doses of bupivacaine result in greater rates of sustained headache relief than lower doses.
Methods: This was a randomized, 4-armed study conducted in 2 EDs. Eligible patients were those with a moderate or severe primary or secondary headache. We randomized patients to unilateral (UL) or bilateral (BL) transnasal SPGB with 0.5% bupivacaine and also to high dose (3 mL) or low dose (1 mL) bupivacaine. Thus, participants could have received 1 mL, 2 mL, 3 mL, or 6 mL of bupivacaine. No attempts were made to blind study participants or investigators. We did not use a sham procedure. We assessed pain using the descriptors severe, moderate, mild, or none. The primary outcome was sustained headache relief, defined as achieving a headache intensity of mild or none within 2 hours of medication administration and maintaining a level of mild or none for 48 hours after the procedure without the use of any rescue analgesic medications at any time during the 48 hours. The secondary outcome was the request to receive the same medication during a subsequent visit to the ED for headache. The minimum clinically important between-group difference was an absolute risk reduction of 15% to 20%.
Results: In total, 2,494 patients were screened for eligibility, and 220 were randomized. Of the 2,494 patients, 1,612 (65%) refused participation…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,494 participants or records.
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