PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies

Starting soon · Not applicable

Conditions studied: Esophageal Cancer, Esophagectomy, Multimodal Analgesia, Minimally Invasive Surgery

In brief

Esophageal cancer ranks as the seventh leading cause of cancer globally, with 604,100 new cases, and the sixth leading cause of cancer-related deaths worldwide. When applicable, surgery is the gold standard treatment for resectable oesophageal-esophagogastric junction cancer. The surgical technique requires both an abdominal approach and a transthoracic approach to resect the esophagus, perform the anastomosis, and allow optimal lymph node removal. Surgery Historically, esophagectomy was performed entirely through open surgery. This procedure was complex, associated with significant morbidity and mortality, as well as intense acute and chronic postoperative pain. In this context, thoracic epidural analgesia (TEA) is the gold standard in the management of acute postoperative pain. It allows for opioid sparing and reduces postoperative pulmonary complications. In order to reduce postoperative pain, facilitate postoperative recovery and limit postoperative complications, particularly respiratory complications, the minimally invasive approach has been proposed for several surgical indications. This principle has led to the development of hybrid esophagectomy, i.e. an abdominal approach by laparoscopy and a thoracic approach by right thoracotomy. An abdominal laparoscopic approach during esophagectomy, even in combination with a right thoracotomy, would therefore limit postoperative complications compared to open surgery. In parallel to the wider use of hybrid esophagectomy, some teams have demonstrated the feasibility of a totally minimally invasive esophagectomy (TMIE), first video-assisted, then robot-assisted. The rise of minimally invasive surgery (both hybrid and totally minimally invasive) has led to a decrease in postoperative pain compared to open surgery. Enhanced recovery after surgery protocols have been developed to improve postoperative recovery and management of acute postoperative pain. In this context, thoracic epidural analgesia TEA may prove counterproductive by inducing arterial hypotension requiring vasopressor drugs, acute urinary retention, and limiting mobilization. Moreover, thoracic epidural analgesia TEA failure occurs in 30% of cases. In minimally invasive surgery, it may be inadequate in half of the patients. Paravertebral block (PVB) appears as a satisfactory alternative for postoperative analgesia management. In this sense, PVB is recommended for pain management in thoracoscopic lung. Evidence of the effectiveness and interest of the paravertebral catheter is lacking regarding totally minimally invasive esophageal surgery as most studies demonstrating the benefit of Paravertebral block PVB in esophageal surgery were retrospective.

Key facts

Study ID: NCT07434739
Run by: University Hospital, Lille
People needed: 506
Starts: 2026-05-01
Expected to finish: 2028-10-01
Last updated by the study team: 2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient requiring totally minimally invasive surgical esophagectomy (robot-assisted or not) with 2 Ivor-Lewis type approaches: laparoscopy for the abdominal approach and thoracoscopy for the thoracic approach.
Age ≥ 18 years old
Patient who has given written consent to participate in the trial
Socially insured patient
Patient willing to comply with all study procedures and duration

You may not qualify if…

- Intervention planned by open esophagectomy (laparotomy and/or thoracotomy)
3-stage esophagectomy, McKeown type
Obesity with body mass index ≥ 35 kg.m-2 (due to the foreseeable difficulties arising from this BMI).
Pregnancy
Haemostasis trouble
ASA score > 3
Renal failure (eGFR < 50 mL/min)
Ongoing opioid use (>3 months prior to the day of surgery)
Contraindication to local anesthesia
Local infection
Inability to receive informed information
Person deprived of the liberty
Person benefiting from a system of legal protection (guardianship…)

Where it is running

CHU de Lille — Lille, France

Full record on ClinicalTrials.gov

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