title: 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
creator: Klotz, Rosa
creator: Hofer, Stefan
creator: Schellhaaß, Alexander
creator: Dörr-Harim, Colette
creator: Tenckhoff, Solveig
creator: Bruckner, Thomas
creator: Klose, Christina
creator: Diener, Markus K.
creator: Weigand, Markus A.
creator: Büchler, Markus W.
creator: Knebel, Phillip
subject: 610
subject: 610 Medical sciences Medicine
description: 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
publisher: BioMed Central
date: 2016
type: Article
type: info:eu-repo/semantics/article
type: NonPeerReviewed
format: application/pdf
identifier: https://archiv.ub.uni-heidelberg.de/volltextserverhttps://archiv.ub.uni-heidelberg.de/volltextserver/20541/1/13063_2016_Article_1306.pdf
identifier: DOI:
identifier: urn:nbn:de:bsz:16-heidok-205413
identifier:   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  (2016) 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.  Trials, 17 (194).  pp. 1-10.  ISSN 1468-6694     
relation: https://archiv.ub.uni-heidelberg.de/volltextserver/20541/
rights: info:eu-repo/semantics/openAccess
rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id)
language: eng