Opioid-free Anesthesia and Thoracoscopy Surgery

Study Overview
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Brief Summary
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Evaluation of a service OFA (Opioid-free Anesthesia) protocol on post-operative pain of patients operated on by video-thoracoscopic carcinologic surgery by counting them to a group of patients receiving standard general anesthesia with opioid.

Detailed Description
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A service protocol based on opioid-free anesthesia in patients undergoing pulmonary carcinologic surgery under video-thoracoscopy will be evaluated. The investigative team want to recruit 100 patients prospectively. These patients will be randomly assigned on the day of surgery between OFA (Opioid Free Anesthesia) and OBA (Opioid Based Anesthesia). Anesthesia and analgesia of patients in the OFA group will be performed without morphine according to the validated local protocol. We will use level 1 and 2 analgesics (paracetamol, NSAIDs and nefopam) associated with an erector spine block and anesthesia under propofol, dexmedetomidine and ketamine ivse. Patients in the OBA group will have so-called basic anesthesia and analgesia with opioids according to usual practice. Postoperative pain by collecting morphine consumption in the first 48 hours postoperatively between the two groups will be compared. Chronic neuropathic postoperative pain will also be collected by a telephone questionnaire at 3 months postoperative.

Official Title
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Evaluation of an Opioid Free Anesthesia Protocol in Thoracoscopic Carcinological Thoracic Surgery

Conditions
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Opioid Free Anesthesia, Thoracic Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours Exclusion Criteria: Patient with unstable unstable unstable coronary artery disease, Patient contraindicated for the use of dexmedetomidine: heart rate<50 / min, High degree atrioventricular block (2 and 3) unless fitted (carrier of a pacemaker), Patient on beta-blocker, allergy to Dexdor®, Patient allergic to other drugs used in OFA (Paracetamol and NSAIDs). Renal insufficiency patient with creatinine clearance<30ml/min will not be excluded but will not receive NSAIDs. Minor patient, Adult patient under guardianship or curators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OFA : Opioid Free Anesthesia<br>Opioid-free surgery. Analgesia provided by attenuation analgesic 1, dexmedetomidine, ketamine and general anesthesia by propofol. Regional loco anesthesia is performed in the OFA group and possible in the OBA group. It's local service protocol used since 1 year. | |
| OBA : Opioid Based Anesthesia<br>Conventional anesthesia with Propofol and Sufentanil boli with the possibility of regional loco anesthesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Total morphine consumption over the first 48 post operative hours in milligrammes | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperatory haemodynamic tolerance | Maximum doses of norepinephrine intraoperatively in µg/kg/min. | Day 0 | 
| Quality of intraoperative anesthesia | Duration of surgery (time between entering the operating room and leaving the room) in minutes. | Day 0 | 
| Ileus Postoperative | Presence of postoperative ileus (defined by the presence 2 of the following criteria from the 4th postoperative day: nausea and vomiting, absence of food recovery, no stool or gas in the last 24 hours, abdominal meteorism, radiological arguments) | Day 4 | 
| Duration of hospitalization | Length of hospitalization (Time between arrival at the hospital and discharge) in days. | Day 10 | 
| Chronic neuropathic pain | Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain) | Month-3 | 
| Long-term morphine consumption | Morphine consumption at 3-month (yes/no) | Month-3 | 
| Physical form recovery | Time between surgery and resumption of physical activity in days. | Month-3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video-thoracoscopy, Chronic Pain, Opioid Free Anesthesia, Thoracic surgery