Opioid-free Anesthesia and Thoracoscopy Surgery (OFAT)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Opioid Free Anesthesia; Thoracic Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05308355

RC22_0112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

90 participants in 2 patient groups

OFA : Opioid Free Anesthesia

Description:

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

Description:

Conventional anesthesia with Propofol and Sufentanil boli with the possibility of regional loco anesthesia.