CHU de Nantes
Nantes, 44093, France
NCT Number: NCT05308355
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.
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Notify Me18 year–80 year
All sexes
Observational
Nantes, 44093, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 2
Total morphine consumption over the first 48 post operative hours in milligrammes
Time frame: Day 0
Maximum doses of norepinephrine intraoperatively in µg/kg/min.
Time frame: Day 0
Duration of surgery (time between entering the operating room and leaving the room) in minutes.
Time frame: Day 4
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)
Time frame: Day 10
Length of hospitalization (Time between arrival at the hospital and discharge) in days.
Time frame: Month-3
Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)
Time frame: Month-3
Morphine consumption at 3-month (yes/no)
Time frame: Month-3
Time between surgery and resumption of physical activity in days.
Nantes University Hospital
Other
Evaluation of an "Opioid Free Anesthesia" Protocol in Thoracoscopic Carcinological Thoracic Surgery
Acronym: OFAT
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