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Randomized Controlled Trial
Intravenous Patient-controlled Analgesia Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial.
- John Hausken, Åsmund Avdem Fretland, Bjørn Edwin, Marit Helen Andersen, Vegar Johansen Dagenborg, Gudrun Maria Waaler Bjørnelv, Ronny Kristiansen, Kjetil Røysland, Gunnvald Kvarstein, and Tor Inge Tønnessen.
- Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.
- Ann. Surg. 2019 Aug 1; 270 (2): 193-199.
ObjectiveWe conducted a randomized, controlled, noninferiority trial to investigate if intravenous, multimodal, patient-controlled analgesia (IV-PCA) could be noninferior to multimodal thoracic epidural analgesia (TEA) in patients undergoing open liver surgery.Summary Background DataThe increasing use of minimally invasive techniques and fast track protocols have questioned the position of epidural analgesia as the optimal method of pain management after abdominal surgery.MethodsPatients operated with open liver resection between February 2012 and February 2016 were randomly assigned to receive either IV-PCA enhanced with ketorolac/diclofenac (IV-PCA, n = 66) or TEA (n = 77) within an enhanced recovery after surgery protocol. Noninferiority would be declared if the mean pain score on the numeric rating scale (NRS) for postoperative days (PODs) 0 to 5 in the IV-PCA group was no worse than the mean pain score in the TEA group by a margin of <1 point on an 11-point scale (0-10).ResultsThe primary endpoint, mean NRS pain score was 1.7 in the IV-PCA group and 1.6 in the TEA group, establishing noninferiority. Pain scores were lower in the TEA group on PODs 0 and 1, but higher or equal on PODs 2 and 5. Postoperative hospital stay was significantly shorter for patients in the IV-PCA group (74 vs 104 h, P < 0.001). The total opioid consumption during the first 3 days was significantly lower in the IV-PCA group.ConclusionsIV-PCA was noninferior to TEA for the treatment of postoperative pain in patients undergoing open liver resection.
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