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Intravenous Patient-controlled Analgesia Versus Thoracic Epidural Analgesia After Open Liver Surgery

A Prospective, Randomized, Controlled, Noninferiority Trial

Hausken, John MD*; Fretland, Åsmund Avdem MD†,‡,§; Edwin, Bjørn MD, PhD†,‡,§; Andersen, Marit Helen PhD¶,||; Dagenborg, Vegar Johansen MD**,††,§; Bjørnelv, Gudrun Maria Waaler MPhil†,‡‡; Kristiansen, Ronny BSc†,§§; Røysland, Kjetil PhD¶¶; Kvarstein, Gunnvald MD, PhD||||; Tønnessen, Tor Inge MD, PhD*,§

doi: 10.1097/SLA.0000000000003209
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Objective: We 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 Data: The 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.

Methods: Patients 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).

Results: The 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.

Conclusions: IV-PCA was noninferior to TEA for the treatment of postoperative pain in patients undergoing open liver resection.

*Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

The Intervention Centre, Oslo University Hospital, Oslo, Norway

Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway

§Institute for Clinical Medicine, University of Oslo, Oslo, Norway

Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway

||Department of Health Science, University of Oslo, Oslo, Norway

**Department of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway

††Department of Gastroenterological Surgery, Oslo University Hospital, Oslo, Norway

‡‡Institute of Health and Society, University of Oslo, Oslo, Norway

§§Department of Information Technology, Oslo University Hospital, Oslo, Norway

¶¶Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway

||||Department of Clinical Medicine, UiT, The Arctic University of Norway, Tromsø, Norway.

Reprints: John Hausken, MD, Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, 0027 Oslo, Norway. E-mail: jhausken@ous-hf.no.

The authors report no conflicts of interest.

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