Opioid-free Anesthesia and Thoracoscopy Surgery

Completed

• Conditions: Opioid Free Anesthesia; Thoracic Surgery

• Registration Number: NCT05308355
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-03-25
• Study Start: 2022-04-04
• Study First Posted: 2022-04-04
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morphine consumption	Day 2	Total morphine consumption over the first 48 post operative hours in milligrammes

Secondary Outcome Measures

Name	Time	Method
Preoperatory haemodynamic tolerance	Day 0	Maximum doses of norepinephrine intraoperatively in µg/kg/min.
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.
Quality of intraoperative anesthesia	Day 0	Duration of surgery (time between entering the operating room and leaving the room) in minutes.
Chronic neuropathic pain	Month-3	Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)
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.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France