Clinical trial · Interventional
PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies
PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophagectomy | — | UNRESOLVED | — |
| Minimally Invasive Surgery | — | UNRESOLVED | — |
| Multimodal Analgesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epidural group | Procedure | — | UNRESOLVED |
| paravertebral catheter analgesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paravertebral catheter group
- description
- * Paravertebral block and catheter insertion performed under ultrasound guidance. Puncture in T4-T6 in a parasagittal or transverse direction depending on the practitioner's preference. The catheter will be secured by tunneling under the skin, followed by dressing. * Following catheter induction, administration of 4 mL of ropivacaine \[2 mg/mL\] (if installed the day before the operating room), followed by maintenance with ropivacaine \[2 mg/mL\] at 4 mL/h. * Infiltration of the abdominal trocars with ropivacaine \[2 mg.ml-1\] 20 ml. * Postoperatively: continuous infusion of ropivacaine through the catheter at 8 mg/h.- After induction of the catheter 4 ml of ropivacaine \[2 mg.ml-1\] (if installed the day before the operating room), maintenance with ropivacaine \[2 mg.ml-1\] at 4 ml.h-1.
- interventionNames
- Procedure: paravertebral catheter analgesia
- type
- ACTIVE_COMPARATOR
- label
- Epidural groupe
- description
- * Under strict surgical asepsis, the epidural catheter will be placed after anatomical identification, typically between T4 and T7, to achieve thoracic and abdominal analgesia before the induction of general anesthesia. * A test dose of 4 ml of lidocaine \[10 mg/ml\] will be administered. A cold test will be conducted to ensure proper catheter function. * If the epidural catheter will be placed the day before the operation, induction will occur before surgical incision using ropivacaine \[2 mg.ml-1\] 4 ml, followed by maintenance with ropivacaine \[2 mg.ml-1\] at 4 ml/h. * Postoperatively, Patient Controlled Epidural Analgesia (PCEA) will be administered, providing analgesia upon patient demand with a continuous background infusion of ropivacaine at 8 mg/h, and bolus doses of 6 mg every 30 minutes if requested by the patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * \- 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…)
References
Publications (0)
Data not yet available