Clinical trial NCT05308355: Opioid-free Anesthesia and Thoracoscopy Surgery
Official title: Evaluation of an "Opioid Free Anesthesia" Protocol in Thoracoscopic Carcinological Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Free Anesthesia
Thoracic Surgery
Keywords: Video-thoracoscopy
Chronic Pain
Opioid Free Anesthesia
Thoracic surgery
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing lung oncology surgery under video-thoracoscopy lasting more than 2 hours.

Patients will be randomly assigned to a group without a random draw. Only the anesthesiologist trained at the OFA will be able to do the OFA

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Morphine consumption
timeFrame: Day 2
Secondary outcomes:
measure: Preoperatory haemodynamic tolerance
timeFrame: Day 0
measure: Quality of intraoperative anesthesia
timeFrame: Day 0
measure: Ileus Postoperative
timeFrame: Day 4
measure: Duration of hospitalization
timeFrame: Day 10
measure: Chronic neuropathic pain
timeFrame: Month-3
measure: Long-term morphine consumption
timeFrame: Month-3
measure: Physical form recovery
timeFrame: Month-3
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Julien CADIET, PH
role: PRINCIPAL_INVESTIGATOR
References: