PEPMEN trial van start gegaan

Het doel van de PEPMEN trial is om 2 soorten pijnstilling rondom de slokdarmoperatie te vergelijken. Deze 2 soorten pijnstilling zijn de epiduraal en de paravertebraal. Epidurale pijnstilling wordt ook wel de ruggenprik genoemd en wordt voorafgaand aan de operatie door de anesthesist geplaatst. Paravertebrale pijnstilling is een prik net naast de wervelkolom en wordt tijdens de operatie door de chirurg geplaatst.
De gedachte is dat paravertebrale pijnstilling vergelijkbare pijnstilling biedt en minder bijwerkingen veroorzaakt dan epidurale pijnstilling. De primaire uitkomstmaat is de kwaliteit van herstel, gemeten middels de vragenlijst ‘Quality of Recovery – 40’ op dag 3 postoperatief.
Er doen 4 ziekenhuizen mee aan de PEPMEN trial die sinds januari 2020 open is voor inclusies. Na inclusie worden patiënten geloot tussen paravertebrale dan wel epidurale pijnstilling. Op dag 1,2 en 3 na de operatie wordt de kwaliteit van herstel gemeten aan de hand van vragenlijsten. De verwachting is dat in januari 2022 192 patiënten hebben deelgenomen aan het onderzoek.

Link naar artikel

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

B.F. Kingma ,W.J. Eshuis, E.M. de Groot, M.L.Feenstra, J.P. Ruurda, S.S. Gisbertz, W.ten Hoope, M. Marsman , J. Hermanides , M. W. Hollmann , C. J. Kalkman , M. D. P. Luyer , G. A. P. Nieuwenhuijzen, H.J. Scholten, M.Buise, M.J.van Det, E.A. Kouwenhoven, F. van der Meer, G.W.J. Frederix, E. Cheong , K. al Naimi , M. I. van Berge Henegouwen and R. van Hillegersberg

Abstract

Background: Thoracic 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.

Methods: This 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.

Discussion: In 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 registration: Netherlands Trial Registry, NL8037. Registered 19 September 2019.