OFAT: Opioid-free Anesthesia and Thoracoscopy Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OFA : Opioid Free Anesthesia 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. |
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| OBA : Opioid Based Anesthesia Conventional anesthesia with Propofol and Sufentanil boli with the possibility of regional loco anesthesia. |
Outcome Measures
Primary Outcome Measures
- Morphine consumption [Day 2]
Total morphine consumption over the first 48 post operative hours in milligrammes
Secondary Outcome Measures
- Preoperatory haemodynamic tolerance [Day 0]
Maximum doses of norepinephrine intraoperatively in µg/kg/min.
- Quality of intraoperative anesthesia [Day 0]
Duration of surgery (time between entering the operating room and leaving the room) in minutes.
- Ileus Postoperative [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)
- Duration of hospitalization [Day 10]
Length of hospitalization (Time between arrival at the hospital and discharge) in days.
- Chronic neuropathic pain [Month-3]
Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)
- Long-term morphine consumption [Month-3]
Morphine consumption at 3-month (yes/no)
- Physical form recovery [Month-3]
Time between surgery and resumption of physical activity in days.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patient
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Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours
Exclusion Criteria:
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Patient with unstable unstable unstable coronary artery disease,
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Patient contraindicated for the use of dexmedetomidine: heart rate<50 / min, High degree atrioventricular block (2 and 3) unless fitted (carrier of a pacemaker),
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Patient on beta-blocker, allergy to Dexdor®,
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Patient allergic to other drugs used in OFA (Paracetamol and NSAIDs).
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Renal insufficiency patient with creatinine clearance<30ml/min will not be excluded but will not receive NSAIDs.
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Minor patient,
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Adult patient under guardianship or curators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nantes | Nantes | France | 44093 |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
- Principal Investigator: Julien CADIET, PH, CHU de Nantes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC22_0112