To the Editor We read with interest the article by Klotz et al1 showing that epidural analgesia (EDA) and intravenous analgesia (IVA) have comparable results, but EDA has more shortcomings. We acknowledge the authors’ work, but this randomized trial deserves 3 comments.
First, we question the authors’ choice to calculate the sample size of this multicenter trial taking into account the results of a single monocenter retrospective (and somewhat biased) study.2 The 15% lower occurrence of gastrointestinal complications after IVA compared with EDA has not been replicated elsewhere, the other participating European centers not necessarily observing the same difference. Furthermore, a meta-analysis3 including the previously mentioned study2 and a large cohort study4 failed to show any such difference. In our opinion, given the published literature, a pragmatic approach should be to perform a noninferiority trial instead of a superiority trial.
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Guerin R, Slim K. Should Epidural Analgesia Be Abandoned for Open Pancreatoduodenectomy? JAMA Surg. 2021;156(1):103–104. doi:10.1001/jamasurg.2020.4382
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