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Intravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial

Klotz, Rosa ; Hofer, Stefan ; Schellhaaß, Alexander ; Dörr-Harim, Colette ; Tenckhoff, Solveig ; Bruckner, Thomas ; Klose, Christina ; Diener, Markus K. ; Weigand, Markus A. ; Büchler, Markus W. ; Knebel, Phillip

In: Trials, 17 (2016), Nr. 194. pp. 1-10. ISSN 1468-6694

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Download (767kB) | Lizenz: Creative Commons LizenzvertragIntravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial by Klotz, Rosa ; Hofer, Stefan ; Schellhaaß, Alexander ; Dörr-Harim, Colette ; Tenckhoff, Solveig ; Bruckner, Thomas ; Klose, Christina ; Diener, Markus K. ; Weigand, Markus A. ; Büchler, Markus W. ; Knebel, Phillip underlies the terms of Creative Commons Attribution 3.0 Germany

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Abstract

Background: Despite substantial improvements in surgical and anesthesiological practices leading to decreased mortality of less than 5 % at high-volume centers, pancreatic surgery is still associated with high morbidity rates of up to 50 %. Attention is increasingly directed toward the optimization of perioperative management to reduce complications and enhance postoperative recovery. Currently, two different strategies for postoperative pain management after pancreatoduodenectomy are being routinely used: patient-controlled intravenous analgesia and thoracic epidural analgesia. Evidence is lacking to assess which strategy entails fewer postoperative complications. Methods/design: The PAKMAN trial is designed as an adaptive, pragmatic, randomized, controlled, multicenter, open-label, superiority trial with two parallel study groups. A total of 370 patients scheduled for elective pancreatoduodenectomy will be randomized after giving written informed consent, and 278 patients are needed for analysis. Patients with chronic pancreatitis, severe chronic obstructive pulmonary disease (COPD), American Society of Anesthesiologists (ASA) physical status classification ≥ IV, or chronic pain syndrome will be excluded. The group A intervention includes intraoperative general anesthesia and postoperative patient-controlled intravenous analgesia; the group B intervention comprises combined intraoperative general anesthesia and epidural analgesia with postoperative epidural analgesia. The primary endpoint of this trial is a composite of the gastrointestinal complications (delayed gastric emptying, pancreatic fistula, biliary leak, gastrointestinal bleeding, and postoperative ileus) up to postoperative day 30. The aim is to investigate whether the frequency of gastrointestinal complications following pancreatoduodenectomy can be reduced by 15 % using postoperative, patient-controlled intravenous analgesia compared with epidural analgesia. Discussion: Several previous studies investigating the two different strategies for postoperative pain management have mainly focused on their effectiveness in pain control. However, the PAKMAN trial is the first to compare them with regard to their impact on the surgical endpoint “postoperative gastrointestinal complications” after pancreatoduodenectomy. Trial registration: German Clinical Trials Register, DRKS00007784

Document type: Article
Journal or Publication Title: Trials
Volume: 17
Number: 194
Publisher: BioMed Central
Place of Publication: London
Date Deposited: 15 Apr 2016 12:54
Date: 2016
ISSN: 1468-6694
Page Range: pp. 1-10
Faculties / Institutes: Medizinische Fakultät Heidelberg > Chirurgische Universitätsklinik
Medizinische Fakultät Heidelberg > Universitätsklinik für Anaesthesiologie
Medizinische Fakultät Heidelberg > Institut für Medizinische Biometrie
DDC-classification: 610 Medical sciences Medicine
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