Paravertebral catheter versus epidural analgesia in minimally invasive esophageal
resection: a randomized controlled multicenter trial

Thoracic epidural analgesia is the current standard perioperative pain management modality in esophageal surgery. However, paravertebral analgesia may be an alternative strategy that is associated with equal pain control, but less side effects that contribute to an improved quality of recovery. Therefore, the aim of this multicenter, randomized controlled supriority trial is to compare paravertebral catheter versus thoracic epidural analgesia regarding the quality of recovery, effectiveness of pain control, physical and emotional functioning, side effects, and cost-effectiveness in patients undergoing minimally invasive esophagectomy. Patients who are older than 18 years old, able to provide written informed consent, and scheduled to undergo minimally invasive esophagectomy with an intrathoracic anastomosis and two-field lymphadenectomy (Ivor Lewis procedure) will be included. Randomization will determine whether patients receive paravertebral catheter analgesia combined with patient-controlled intravenous opioids (intervention) or the gold standard of thoracic epidural analgesia (control). A total of 172 patients are required (86 patients in each treatment arm), meaning that 192 patients need to be randomized when assuming 10% loss to follow-up. The primary outcome is the score on 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 day 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 following data will be collected: additional rescue medication on day 0-3, opioid consumption on day 0-3, technical failure of the pain treatment, duration of anesthesia time, 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.

Paravertebral analgesia is associated with superior quality of recovery by achieving comparable pain control whilst having less side-effects.

Data will be collected preoperatively (baseline), from postoperative day 0 until hospital discharge, at 3 months postoperative follow-up, and at 6 months postoperative follow-up.

Paravertebral catheter analgesia combined with patient-controlled intravenous opioids.