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Κυριακή 3 Δεκεμβρίου 2017

Randomized Clinical Trial of Preoperative High-Dose Methylprednisolone on Postoperative Pain at Rest After Laparoscopic Appendectomy

BACKGROUND: Methylprednisolone administered intravenously preoperatively has been shown to reduce pain, nausea, and fatigue after elective surgery. We aimed to show that 125 mg of methylprednisolone given intravenously 30 minutes before laparoscopic surgery for suspected appendicitis would reduce pain at rest during the first 3 postoperative days. METHODS: A multicenter, parallel-group, double-blind, placebo-controlled study was conducted including patients 18 years of age and older with an American Society of Anesthesiologist class of I–III undergoing laparoscopic surgery for suspected appendicitis. The primary outcome was pain at rest measured on the 11-point numerical rating scale 5 times during the first 3 days after surgery. The effect of 125 mg of methylprednisolone on postoperative pain at rest during the first 3 days was assessed using a mixed-effects model with time and intervention as main effects. RESULTS: From April 2016 to August 2016, 78 patients were included, and all were eligible for analysis of the primary outcome. The estimated effect of 125 mg of methylprednisolone on pain at rest during the first 3 days after surgery was a nonsignificant increase of 0.2 (95% confidence interval, −0.5 to 0.9; P = .571) on the 11-point numerical rating scale. There was no difference between the 2 groups regarding the need for opioid agonists during hospital stay on the first postoperative day (P = .381). CONCLUSIONS: A 125-mg dose of methylprednisolone given intravenously 30 minutes before laparoscopic surgery for appendicitis seemed no better than placebo at providing a clinical meaningful reduction in postoperative pain at rest. Accepted for publication October 24, 2017. Funding: This work was supported by the A.P. Møller Foundation for the Advancement of Medical Science, Grosserer L.F. Foghts Fond, and the Augustinus Foundation. The primary author received a research grant from Nordsjællands Hospital and financial support from the Department of Surgery, Nordsjællands Hospital, Copenhagen University Hospital. The authors declare no conflicts of interest. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website (http://ift.tt/KegmMq). Trial Registration: Registered at http://ift.tt/PmpYKN (NCT02711449) and EudraCT (2015-004800-46). All authors agree to be accountable for all aspects of the work presented. Reprints will not be available from the authors. Address correspondence to Jakob Kleif, MD, Department of Surgery, Nordsjællands Hospital, Copenhagen University Hospital, Dyrehavevej 29, 3400 Hillerød, Denmark. Address e-mail to kleifen@dadlnet.dk. © 2017 International Anesthesia Research Society

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