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

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.

• Authors: Rosa Klotz, Jan Larmann, Christina Klose, Thomas Bruckner, Laura Benner, Colette Doerr-Harim, Solveig Tenckhoff, Johan F Lock, Elmar-Marc Brede, Roberto Salvia, Enrico Polati, Jörg Köninger, Jan-Henrik Schiff, Uwe A Wittel, Alexander Hötzel, Tobias Keck, Carla Nau, Anca-Laura Amati, Christian Koch, Thomas Eberl, Michael Zink, Ales Tomazic, Vesna Novak-Jankovic, Stefan Hofer, Markus K Diener, Markus A Weigand, Markus W Büchler, Phillip Knebel, PAKMAN Trial Group
• Journal: JAMA surgery (JAMA Surg) Vol. 155 Issue 7 Pg. e200794 (07 01 2020) ISSN: 2168-6262 [Electronic] United States
• PMID: 32459322 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Aged
• Analgesia, Epidural
• Analgesia, Patient-Controlled
• Female
• Gastrointestinal Diseases (epidemiology, etiology)
• Humans
• Male
• Middle Aged
• Pain, Postoperative (prevention & control)
• Pancreaticoduodenectomy (adverse effects)
• Postoperative Complications (epidemiology, etiology)