Paravertebral catheter versus EPidural analgesia in Minimally invasive Esophageal resectioN: a randomized controlled multicenter trial (PEPMEN trial).

B Feike Kingma ,F Van Der Meer,K Al Naimi,Ewout A Kouwenhoven ,Misha Luyer ,Jeroen Hermanides ,Harm J Scholten ,Marc J Van Det ,Grard A P Nieuwenhuijzen ,Suzanne S Gisbertz ,Jelle P Ruurda ,Edward Cheong ,Eline M De Groot ,Geert Frederix ,Marc P Buise ,Wietse J Eshuis ,Cor J Kalkman ,Werner Ten Hoope ,Mark I Van Berge Henegouwen ,Markus W Hollmann ,Minke L Feenstra ,Marije Marsman ,Richard Van Hillegersberg

doi:10.1186/s12885-020-6585-1

Abstract

BackgroundThoracic epidural analgesia is the standard postoperative pain management strategy in esophageal cancer surgery. However, paravertebral block analgesia may achieve comparable pain control while inducing less side effects, which may be beneficial for postoperative recovery. This study primarily aims to compare the postoperative quality of recovery between paravertebral catheter versus thoracic epidural analgesia in patients undergoing minimally invasive esophagectomy.MethodsThis study represents a randomized controlled superiority trial. A total of 192 patients will be randomized in 4 Dutch high-volume centers for esophageal cancer surgery. Patients are eligible for inclusion if they are at least 18 years old, able to provide written informed consent and complete questionnaires in Dutch, scheduled to undergo minimally invasive esophagectomy with two-field lymphadenectomy and an intrathoracic anastomosis, and have no contra-indications to either epidural or paravertebral analgesia. The primary outcome is the quality of postoperative recovery, as measured by the Quality of Recovery-40 (QoR-40) questionnaire on the morning of postoperative day 3. Secondary outcomes include the QoR-40 questionnaire score Area Under the Curve on postoperative days 1–3, the integrated pain and systemic opioid score and patient satisfaction and pain experience according to the International Pain Outcomes (IPO) questionnaire, and cost-effectiveness. Furthermore, the groups will be compared regarding the need for additional rescue medication on postoperative days 0–3, technical failure of the pain treatment, duration of anesthesia, duration of surgery, total postoperative fluid administration day 0–3, postoperative vasopressor and inotrope use, length of urinary catheter use, length of hospital stay, postoperative complications, chronic pain at six months after surgery, and other adverse effects.DiscussionIn this study, it is hypothesized that paravertebral analgesia achieves comparable pain control while causing less side-effects such as hypotension when compared to epidural analgesia, leading to shorter postoperative length of stay on a monitored ward and superior quality of recovery. If this hypothesis is confirmed, the results of this study can be used to update the relevant guidelines on postoperative pain management for patients undergoing minimally invasive esophagectomy.Trial registrationNetherlands Trial Registry, NL8037. Registered 19 September 2019.

Highlights

Thoracic epidural analgesia is the standard postoperative pain management strategy in esophageal cancer surgery
Thoracic epidural analgesia has long been the gold standard for pain management following esophagectomy
Paravertebral analgesia is increasingly suggested as a good alternative for patients undergoing minimally invasive esophagectomy (MIE), as the catheter can be placed under direct thoracoscopic vision possibly reduces the incidence of hypotensive events

Summary

Introduction

Thoracic epidural analgesia is the standard postoperative pain management strategy in esophageal cancer surgery. This study primarily aims to compare the postoperative quality of recovery between paravertebral catheter versus thoracic epidural analgesia in patients undergoing minimally invasive esophagectomy. Traditional open transthoracic esophagectomy is associated with substantial postoperative thoracic pain, mainly due to the large intercostal incision, which may lead to decreased mobility, (pulmonary) complications, and delayed recovery [4]. In this light, adequate pain management is essential during the early postoperative phase. Over the last decades, minimally invasive esophagectomy (MIE) is increasingly adopted, which is associated with less postoperative pain when compared to open surgery [7,8,9]. The value of epidural analgesia for MIE needs to be reconsidered in a state-of-the-art treatment setting

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Conclusion