1. Paravertebral catheter versus EPidural analgesia in Minimally invasive Esophageal resectioN
- Author
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Jeroen Hermanides, M. W. Hollmann, M. Buise, B F Kingma, Suzanne S. Gisbertz, Ewout A. Kouwenhoven, M. J. van Det, F. van der Meer, R. van Hillegersberg, Jelle P. Ruurda, M. I. van Berge Henegouwen, E. C. B. M. de Groot, M. Luyer, G.A.P. Nieuwenhuijzen, M L Feenstra, Marije Marsman, G. W. J. Frederix, Wietse J. Eshuis, Edward Cheong, Cor J. Kalkman, H.J. Scholten, K. al Naimi, W. ten Hoope, Surgery, VU University medical center, CCA - Cancer Treatment and quality of life, Signal Processing Systems, Center for Care & Cure Technology Eindhoven, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA -Cancer Center Amsterdam, AGEM - Endocrinology, metabolism and nutrition, CCA - Cancer Treatment and Quality of Life, Anesthesiology, AGEM - Re-generation and cancer of the digestive system, APH - Quality of Care, ACS - Heart failure & arrhythmias, ACS - Microcirculation, and ACS - Diabetes & metabolism
- Subjects
Male ,Cancer Research ,Esophageal Neoplasms ,medicine.medical_treatment ,SDG 3 – Goede gezondheid en welzijn ,Study Protocol ,0302 clinical medicine ,Postoperative Period ,Netherlands ,Pain Measurement ,Aged, 80 and over ,Pain, Postoperative ,Chronic pain ,Nerve Block ,Middle Aged ,Esophageal cancer ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Analgesia, Epidural ,Analgesics, Opioid ,Catheter ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Anesthesia ,Female ,030211 gastroenterology & hepatology ,Adult ,Adolescent ,lcsh:RC254-282 ,Catheterization ,Young Adult ,03 medical and health sciences ,Patient satisfaction ,SDG 3 - Good Health and Well-being ,Multicenter trial ,medicine ,Genetics ,Journal Article ,Humans ,Minimally Invasive Surgical Procedures ,Pain Management ,Paravertebral Block ,Adverse effect ,Aged ,business.industry ,Length of Stay ,medicine.disease ,Esophagectomy ,Lymphadenectomy ,business - 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.
- Published
- 2020