PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- 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
Trial design
Design model
Parallel
Treatments tested in this trial
paravertebral catheter analgesia
Procedure/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 group
Procedure/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.
Treatment groups
506 Participants
are divided into 2 treatment groupsGroup A: Paravertebral catheter groupExperimental treatment 1 intervention
Group B: Epidural groupeActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Postoperative day 3Secondary outcomes
1
Cumulative dose of norepinephrine consumption in milligrams within the first 3 postoperative days.
Time frame
wtithin 3 postoperative days2
Cumulated duration of daily chair mobilization within the first 3 postoperative day
Time frame
wtithin 3 postoperative days3
Frequency of patients with acute urinary retention leading to urinary catheterization within the first 3 postoperative days.
Time frame
wtithin 3 postoperative days4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Grants from Health Ministery National Hospital Clinical Research Program
Collaborator
Source ClinicalTrials.gov