RESUMEN
BACKGROUND: Lidocaine is commonly applied to improve the tolerance of esophageal manometry (EM) and ambulatory pH monitoring (PM). We recently published data suggesting a benefit to this practice and we aimed to confirm these findings in a randomized trial. METHODS: We conducted a double-blind, randomized trial of lidocaine nasal spray versus placebo (saline) before EM and PM. Patients referred to our center who met inclusion criteria were enrolled. Patients were asked to fill a questionnaire after their test and patient-reported adverse effects were compared. KEY RESULTS: Three hundred and four patients were enrolled in our trial. Lidocaine and placebo groups were demographically similar. The primary outcome, pain during catheter insertion, occurred in 60/148 (40.5%) patients in the lidocaine group versus in 72/152 (47.4%) patients in the placebo group (OR: 0.76 [95% CI: 0.48-1.20]; p = 0.23). Patients receiving lidocaine were less likely to report nausea during test recording (OR: 0.48 [95% CI: 0.24-0.91]; p = 0.02) and reported slightly lower intensity of pain during both catheter insertion and test recording (4.68 ± 2.06 versus 5.41 ± 2.24 on 10; p = 0.048 and 3.71 ± 2.00 versus 4.93 ± 2.55 on 10; p = 0.03, respectively). Furthermore, patients receiving lidocaine were less likely to report their test as globally uncomfortable and painful (57% vs. 75%; p = 0.003 and 14% vs. 21%; p = 0.02, respectively). No events of systemic lidocaine toxicity occurred during the study period. CONCLUSIONS: Routine use of lidocaine before esophageal function tests does not reduce pain during catheter insertion but may provide other modest benefits with limited toxicity.