Nebulized lignocaine for topical anaesthesia in no-sedation bronchoscopy (NEBULA): A randomized, double blind, placebo-controlled trial.

Abstract

Background:The role of nebulized lignocaine administration for flexible bronchoscopy is unclear.Methods:In this randomized, double-blind, placebo-controlled trial, subjects undergoing diagnostic flexible bronchoscopy were randomized to receive either nebulized lignocaine (2.5 ml of 4% lignocaine) or nebulized (2.5 ml of 0.9%) saline (placebo). All received 10% lignocaine pharyngeal spray (4 sprays) and 5-ml nasal 2% lignocaine gel. 1% lignocaine solution was used for spray-as-you-go administration in all. Co-primary outcomes were Operator-rated overall procedure satisfaction and Operator-rated cough scores on Visual Analog Scale (VAS). Secondary objectives were cumulative lignocaine dose, proportion of subjects receiving >8.2-mg/kg lignocaine, and complications between the groups.Results:Two hundred and twenty subjects were randomized and 217 (109 – nebulized lignocaine and 108 – placebo) received the intervention. Baseline characteristics were comparable. Operator-rated overall procedure satisfaction scores on VAS (7.30 ± 1.54 nebulized lignocaine and 7.50 ± 1.31 placebo group, P = 0.85) and Operator-rated cough scores on VAS (3 [2–5] nebulized lignocaine and 3 [2–4] placebo group, P = 0.18) were similar. Cumulative lignocaine dose was significantly greater in nebulized lignocaine group (331.46 ± 9.41 mg vs. 232.22 ± 12.77 mg, P < 0.001), and a significantly greater number of subjects in this group received lignocaine dose >8.2 mg/kg. Minor complications occurred in 6 and 9 subjects in nebulized lignocaine and placebo groups, respectively, P = 0.41.Conclusion:Administration of nebulized lignocaine in addition to pharyngeal lignocaine spray, during no-sedation bronchoscopy, increases the cumulative lignocaine dose without improved procedural comfort. Additional nebulized lignocaine during bronchoscopy is not recommended.