Abstract
BackgroundDespite 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/designThe 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.DiscussionSeveral 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 registrationGerman Clinical Trials Register, DRKS00007784Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1306-4) contains supplementary material, which is available to authorized users.
Highlights
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 %
Several previous studies investigating the two different strategies for postoperative pain management have mainly focused on their effectiveness in pain control
The PAKMAN trial is the first to compare them with regard to their impact on the surgical endpoint “postoperative gastrointestinal complications” after pancreatoduodenectomy
Summary
Previous research comparing IV-PCA and EDA has focused mainly on the level of pain control itself [4, 23] or on the incidence of cardiac and pulmonary complications [4, 6]. The postulated benefits of EDA are reduced consumption of anesthetics, improved pain control with higher patient satisfaction, reduced incidence of cardiac and pulmonary complications, reduction of the surgical stress response, early bowel recovery, and enhanced postoperative recovery with shorter hospital stay [4, 6]. Despite these postulated benefits, the influence of EDA on clinically relevant outcomes is not clear [26]. All authors revised the manuscript critically, and all authors read and approved the protocol manuscript
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