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Original Investigation
May 27, 2020

Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial

Author Affiliations
  • 1Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany
  • 2The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany
  • 3Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany
  • 4Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany
  • 5Department of General, Visceral, Transplant, Vascular and Paediatric Surgery, University Hospital of Würzburg, Würzburg, Germany
  • 6Department of Anaesthesiology and Critical Care, University Hospital of Würzburg, Würzburg, Germany
  • 7Surgical and Oncological Department, Pancreas Institute, University Hospital Trust, Verona, Italy
  • 8Department of Anaesthesiology and Intensive Care, Verona University Hospital, Verona, Italy
  • 9Department of General, Visceral, Thorax and Transplantation Surgery, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany
  • 10Department of Anaesthesiology and Operative Intensive Care, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany
  • 11Department of Anesthesiology and Intensive Care, Philipps-University Marburg, Marburg, Germany
  • 12Department of General and Visceral Surgery, Medical Centre, University of Freiburg, Freiburg, Germany
  • 13Department of Anaesthesiology and Critical Care, Medical Centre, University of Freiburg, Freiburg, Germany
  • 14Department of Surgery, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany
  • 15Department of Anaesthesiology and Intensive Care, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany
  • 16Department of Visceral, Thoracic, Transplant and Paediatric Surgery, Justus Liebig University of Giessen, Giessen, Germany
  • 17Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, Giessen, Germany
  • 18Department of Surgery, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria
  • 19Department of Anaesthesiology and Intensive Care Medicine, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria
  • 20Department of Abdominal Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia
  • 21Clinical Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia
JAMA Surg. 2020;155(7):e200794. doi:10.1001/jamasurg.2020.0794
Key Points

Question  Does postoperative patient-controlled intravenous analgesia decrease the occurrence of gastrointestinal complications after pancreatic surgery compared with perioperative thoracic epidural analgesia?

Findings  In this randomized clinical trial of 248 patients, the primary end point of gastrointestinal complications after pancreatic surgery did not differ between patients receiving postoperative patient-controlled intravenous analgesia and those receiving perioperative thoracic epidural analgesia.

Meaning  The choice between patient-controlled intravenous analgesia and thoracic epidural analgesia after pancreatic surgery should not be based on concerns regarding gastrointestinal complications; the 2 methods are comparable with regard to effectiveness and safety.

Abstract

Importance  Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications.

Objective  To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA.

Design, Setting, and Participants  In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol.

Interventions  Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA.

Main Outcomes and Measures  The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution.

Results  Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31 [25.0%]; P = .04). Failure of EDA occurred in 23 patients (18.5%).

Conclusions and Relevance  This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings.

Trial Registration  German Clinical Trials Register: DRKS00007784

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