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PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies

Study acronym: PACEMIE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 52 days later May 1, 2028 → Jun 22, 2028
See other at-risk trials from University Hospital, Lille

Record History

  1. Notable Recruitment openedv2 Show 4 more changesShow less
    • Primary completion pushed from May 1, 2028 to Jun 22, 2028
    • Study completion pushed from Oct 1, 2028 to Nov 22, 2028
    • Start date changed from estimate of May 1, 2026 to Jun 22, 2026
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07434739
Lead Sponsor University Hospital, Lille
Collaborators: Grants from Health Ministery National Hospital Clinical Research Program
Conditions
(from sponsor)
Esophageal Cancer, Esophagectomy, Multimodal Analgesia, Minimally Invasive Surgery
Related terms Esophageal Neoplasms
Enrollment 506 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov