PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies

Official title

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

Overview

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.

Interventions

• 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. * Infi
• 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 befo

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Cumulative dose of norepinephrine consumption in milligrams within the first 3 postoperative days. [Time frame: wtithin 3 postoperative days]
• Cumulated duration of daily chair mobilization within the first 3 postoperative day [Time frame: 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]
• 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]
• 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]
• 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]
• Cumulative morphine consumption in milligrams within the first 3 postoperative days. [Time frame: 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]
• 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]
• Number of days in ICU and at hospital [Time frame: 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]
• 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]

Eligibility criteria

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…)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• CHU de Lille — Lille

Identifiers

NCT: NCT07434739 · 2024_0470

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗