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

February 19, 2026 updated by: University Hospital, Lille

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
506

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Postoperative day 3
Postoperative day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cumulative dose of norepinephrine consumption in milligrams within the first 3 postoperative days.
Time Frame: wtithin 3 postoperative days
wtithin 3 postoperative days
Cumulated duration of daily chair mobilization within the first 3 postoperative day
Time Frame: wtithin 3 postoperative days
wtithin 3 postoperative days
Frequency of patients with acute urinary retention leading to urinary catheterization within the first 3 postoperative days.
Time Frame: wtithin 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.
Time Frame: wtithinat 3 and 6 months
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.
Time Frame: wtithinat 3 and 6 months
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
Time Frame: wtithinat 3 and 6 months
wtithinat 3 and 6 months
Cumulative morphine consumption in milligrams within the first 3 postoperative days.
Time Frame: wtithin 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.
Time Frame: wtithin 3 postoperative days
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
Time Frame: wtithin 3 postoperative days and at 3 and 6 months
wtithin 3 postoperative days and at 3 and 6 months
Number of days in ICU and at hospital
Time Frame: wtithin 3 postoperative days and at 3 and 6 months
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
Time Frame: within 3 postoperative days
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
Time Frame: within 3 postoperative days
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
Time Frame: within 3 postoperative days
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
Time Frame: within 3 postoperative days
within 3 postoperative days
Frequency of patients with at least one serious complication defined as a Dindo-Clavien grade III or higher.
Time Frame: within 3 postoperative days
within 3 postoperative days
Economic evaluation: Incremental net monetary benefit curve over a range of cost-effectiveness thresholds (0-200,000€)
Time Frame: wtithin 6 months
wtithin 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Grants from Health Ministery National Hospital Clinical Research Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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