PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies (PACEMIE)

PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer; Multimodal Analgesia; Minimally Invasive Surgery; Esophagectomy
• Intervention / Treatment: Procedure: paravertebral catheter analgesia; Procedure: Epidural group

• Study Type: Interventional
• Enrollment (Estimated): 506
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cédric CIRENEI,, MD; Phone Number: 03 20 44 59 62; Email: cedric.cirenei@chru-lille.fr

Study Locations

• France
  • Lille, France
    • CHU de Lille
    • Contact: Cédric CIRENEI,, MD; Phone Number: 03 20 44 59 62; Email: cedric.cirenei@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paravertebral catheter group; 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.	Procedure: paravertebral catheter analgesia; Paravertebral catheter group:; 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.
Active Comparator: Epidural groupe; 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.	Procedure: Epidural group; Control group (epidural analgesia as usual):; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The non-inferiority of paravertebral catheter analgesia compared to epidural analgesia in terms of quality of recovery (QoR-15) on postoperative day three in patients undergoing totally minimally invasive esophageal cancer surgery.	Postoperative day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative dose of norepinephrine consumption in milligrams within the first 3 postoperative days.	wtithin 3 postoperative days
Cumulated duration of daily chair mobilization within the first 3 postoperative day	wtithin 3 postoperative days
Frequency of patients with acute urinary retention leading to urinary catheterization within the first 3 postoperative days.	wtithin 3 postoperative days
Change from baseline in pain levels at 3 and 6 months after surgery assessed by using a numerical rating scale.	wtithinat 3 and 6 months
Change from baseline in pain levels at 3 and 6 months after surgery assessed by using the Douleur Neuropatique 4 (DN4)score.	wtithinat 3 and 6 months
Change from baseline in the quality-of-life level at 3 and 6 months after surgery assessed using th euroQol 5 Dimensions - 5 Levels (Eq-5D- 5L) questionnaire	wtithinat 3 and 6 months
Cumulative morphine consumption in milligrams within the first 3 postoperative days.	wtithin 3 postoperative days
Pain levels at rest and at mobilization day 1, day 2 and day 3 assessed using a numerical rating scale.	wtithin 3 postoperative days
Failure rate of the regional anesthesia technique defined by: -Failure of epidural or paravertebral catheterization -No sensory level after injection of a lidocaine test dose of 30 mg during the cold test	wtithin 3 postoperative days and at 3 and 6 months
Number of days in ICU and at hospital	wtithin 3 postoperative days and at 3 and 6 months
Frequency of patients with at least one adverse event due to analgesia technique: - Pneumothorax - Hematoma - Catheter insertion site infection	within 3 postoperative days
Frequency of patients with at least one pulmonary complication defined according to the Esophagectomy Complication Consensus Group classification during hospital length of stay	within 3 postoperative days
Frequency of patients with at least one anastomotic leakage during hospital length of stay according to the the Esophagectomy Complication Consensus Group classification	within 3 postoperative days
Frequency of patients with at least one surgical complication during hospital length of stay according to the Esophagectomy Complication Consensus Group classification	within 3 postoperative days
Frequency of patients with at least one serious complication defined as a Dindo-Clavien grade III or higher.	within 3 postoperative days
Economic evaluation: Incremental net monetary benefit curve over a range of cost-effectiveness thresholds (0-200,000€)	wtithin 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Grants from Health Ministery National Hospital Clinical Research Program

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Epidural; Multimodal analgesia; Paravertebral; Minimally Invasive surgery; Esophagectomies
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 2024_0470

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No