Ultrasound-Guided Suprazygomatic Nerve Blocks to the Pterygopalatine Fossa: A Safe Procedure.

OBJECTIVES: Large-scale procedural safety data on pterygopalatine fossa nerve blocks (PPFBs) performed via a suprazygomatic, ultrasound-guided approach are lacking, leading to hesitancy surrounding this technique. The aim of this study was to characterize the safety of PPFB. METHODS: This retrospective chart review examined the records of adults who received an ultrasound-guided PPFB between January 1, 2016, and August 30, 2020, at the University of Florida. Indications included surgical procedures and nonsurgical pain. Clinical data describing PPFB were extracted from medical records. Descriptive statistics were calculated for all variables, and quantitative variables were analyzed with the paired t test to detect differences between before and after the procedure. RESULTS: A total of 833 distinct PPFBs were performed on 411 subjects (59% female, mean age 48.5 years). Minor oozing from the injection site was the only reported side effect, in a single subject. Although systolic blood pressure, heart rate, and oxygen saturation were significantly different before and after the procedure (132.3 vs 136.4 mm Hg, P < 0.0001; 78.2 vs 80.8, P = 0.0003; and 97.8% vs 96.3%, P < 0.0001; respectively), mean arterial pressure and diastolic blood pressure were not significantly different (96.2 vs 97.1 mm Hg, P = 0.1545, and 78.2 vs 77.4 mm Hg, P = 0.1314, respectively). Similar results were found within subgroups, including subgroups by sex, race, and indication for PPFB. DISCUSSION: We have not identified clinically significant adverse effects from PPFB performed with an ultrasound-guided suprazygomatic approach in a large cohort in the hospital setting. PPFBs are a safe and well-tolerated pain management strategy; however, prospective multicenter studies are needed.

Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol.

BACKGROUND: Nearly one in three unconscious cardiac arrest survivors experience post-anoxic status epilepticus (PASE). Historically, PASE has been deemed untreatable resulting in its exclusion from status epilepticus clinical trials. However, emerging reports of survivors achieving functional independence following early and aggressive treatment of PASE challenged this widespread therapeutic nihilism. In the absence of proven therapies specific to PASE, standard of care treatment leans on general management strategies for status epilepticus. Vigabatrin-an approved therapy for refractory focal-onset seizures in adults-inhibits the enzyme responsible for GABA catabolism, increases brain GABA levels and may act synergistically with anesthetic agents to abort seizures. Our central hypothesis is that early inhibition of GABA breakdown is possible in the post-cardiac arrest period and may be an effective adjunctive treatment in PASE. METHODS: This is a phase IIa, single-center, open-label, pilot clinical trial with blinded outcome assessment, of a single dose of vigabatrin in 12 consecutive PASE subjects. Subjects will receive a single loading dose of 4500 mg of vigabatrin (or dose adjusted in moderate and severe renal impairment) via enteric tube within 48 h of PASE onset. Vigabatrin levels will be monitored at 0- (baseline), 0.5-, 1-, 2-, 3-, 6-, 12-, 24-, 48-, 72- and 168-h (7 days) post-vigabatrin. Serum biomarkers of neuronal injury will be measured at 0-, 24-, 48-, 72- and 96-h post-vigabatrin. The primary feasibility endpoint is the proportion of enrolled subjects among identified eligible subjects receiving vigabatrin within 48 h of PASE onset. The primary pharmacokinetic endpoint is the measured vigabatrin level at 3 h post-administration. Descriptive statistics with rates and proportions will be obtained regarding feasibility outcomes, along with the noncompartmental method for pharmacokinetic analyses. The area under the vigabatrin concentration-time curve in plasma from zero to the time of the last quantifiable concentration (AUC0-tlqc) will be calculated to estimate dose-linear pharmacokinetics. PERSPECTIVE: Vigabatrin demonstrates high potential for synergism with current standard of care therapies. Demonstration of the feasibility of vigabatrin administration and preliminary safety in PASE will pave the way for future efficacy and safety trials of this pharmacotherapeutic. Trial Registration NCT04772547.