Hypnosis Versus Placebo During Atrial Flutter Ablation: The PAINLESS Study: A Randomized Controlled Trial.

ABSTRACT

OBJECTIVES: The aim of this study was to assess the superiority of hypnosis versus placebo on pain perception and morphine consumption during typical atrial flutter (AFL) ablation. BACKGROUND: AFL ablation commonly requires intravenous opioid for analgesia, which can be associated with adverse outcomes. Hypnosis is an alternative technique with rising interest, but robust data in electrophysiological procedures are lacking. METHODS: This single center, randomized controlled trial compared hypnosis and placebo during AFl ablation. In addition to the randomized intervention, all patients were treated according to the institution's standard of care analgesia protocol (administration of 1 mg of intravenous morphine in case of self-reported pain ≥5 on an 11-point numeric rating scale or on demand). The primary endpoint was perceived pain quantified by patients using a visual analog scale. RESULTS: Between October 2017 and September 2019, 113 patients (mean age 70 ± 12 years, 21% women) were randomized to hypnosis (n = 56) or placebo (n = 57). Mean pain score was 4.0 ± 2.2 in the hypnosis group versus 5.5 ± 1.8 in the placebo group (p < 0.001). Pain perception, assessed every 5 min during the whole procedure, was consistently lower in the hypnosis group. Patients' sedation scores were also better in the hypnosis group than in the placebo group (8.3 ± 2.2 vs. 5.4 ± 2.5; p < 0.001). Finally, morphine requirements were significantly lower in the hypnosis group (1.3 ± 1.3 mg) compared with the placebo group (3.6 ± 1.8 mg; p < 0.001). CONCLUSIONS: In this first randomized trial, hypnosis during AFL ablation was superior to placebo for alleviating pain and reducing morphine consumption.