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Esophageal CancerPACEMIENCT07434739

PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies

A study testing paravertebral catheter analgesia and Epidural group in people with Esophageal Cancer and Esophagectomy, run by University Hospital, Lille at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
paravertebral catheter analgesia and Epidural group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
506 participants
Where
1 siteFrance
Study dates
22 Jun 2026to 22 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • - 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
Show all 13Show fewer
  • 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…)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cédric CIRENEI,, MD contact

03 20 44 59 62

cedric.cirenei@chru-lille.fr

France1 site, 1 recruiting
  • CHU de Lille

    Lille

    Cédric CIRENEI,, MD, 03 20 44 59 62, cedric.cirenei@chru-lille.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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.

Being tested
paravertebral catheter analgesia, Epidural group
Keywords
Minimally Invasive surgery, Multimodal analgesia, Paravertebral, Epidural, Esophagectomies
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paravertebral catheter analgesiaProcedure or surgery

    • 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.
  • Epidural groupProcedure or surgery

    • 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.
Study groups in NCT07434739
Study groupRoleWhat they receive
Paravertebral catheter groupExperimental* 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.
Receives: Procedure: paravertebral catheter analgesia
Epidural groupeActive comparator* 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.
Receives: Procedure: Epidural group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Postoperative day 3

Secondary outcomes (16)
  1. Cumulative dose of norepinephrine consumption in milligrams within the first 3 postoperative days.

    Measured: wtithin 3 postoperative days

  2. Cumulated duration of daily chair mobilization within the first 3 postoperative day

    Measured: wtithin 3 postoperative days

  3. Frequency of patients with acute urinary retention leading to urinary catheterization within the first 3 postoperative days.

    Measured: wtithin 3 postoperative days

  4. Change from baseline in pain levels at 3 and 6 months after surgery assessed by using a numerical rating scale.

    Measured: wtithinat 3 and 6 months

  5. Change from baseline in pain levels at 3 and 6 months after surgery assessed by using the Douleur Neuropatique 4 (DN4)score.

    Measured: wtithinat 3 and 6 months

  6. 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

    Measured: wtithinat 3 and 6 months

  7. Cumulative morphine consumption in milligrams within the first 3 postoperative days.

    Measured: wtithin 3 postoperative days

  8. Pain levels at rest and at mobilization day 1, day 2 and day 3 assessed using a numerical rating scale.

    Measured: wtithin 3 postoperative days

  9. 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

    Measured: wtithin 3 postoperative days and at 3 and 6 months

  10. Number of days in ICU and at hospital

    Measured: wtithin 3 postoperative days and at 3 and 6 months

  11. Frequency of patients with at least one adverse event due to analgesia technique: - Pneumothorax - Hematoma - Catheter insertion site infection

    Measured: within 3 postoperative days

  12. Frequency of patients with at least one pulmonary complication defined according to the Esophagectomy Complication Consensus Group classification during hospital length of stay

    Measured: within 3 postoperative days

  13. Frequency of patients with at least one anastomotic leakage during hospital length of stay according to the the Esophagectomy Complication Consensus Group classification

    Measured: within 3 postoperative days

  14. Frequency of patients with at least one surgical complication during hospital length of stay according to the Esophagectomy Complication Consensus Group classification

    Measured: within 3 postoperative days

  15. Frequency of patients with at least one serious complication defined as a Dindo-Clavien grade III or higher.

    Measured: within 3 postoperative days

  16. Economic evaluation: Incremental net monetary benefit curve over a range of cost-effectiveness thresholds (0-200,000€)

    Measured: wtithin 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start22 Jun 2026
  3. Primary completion22 Jun 2028 (estimated)
  4. Study completion22 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
506 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07434739
Sponsor's protocol ID
2024_0470
Acronym
PACEMIE
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
14 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing paravertebral catheter analgesia and Epidural group in people with Esophageal Cancer and Esophagectomy, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cédric CIRENEI,, MD (03 20 44 59 62, cedric.cirenei@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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