Opioid-free Anesthesia and Thoracoscopy Surgery (OFAT)

Evaluation of an "Opioid Free Anesthesia" Protocol in Thoracoscopic Carcinological Thoracic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery; Opioid Free Anesthesia

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
OBA : Opioid Based Anesthesia; Conventional anesthesia with Propofol and Sufentanil boli with the possibility of regional loco anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Total morphine consumption over the first 48 post operative hours in milligrammes	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperatory haemodynamic tolerance	Maximum doses of norepinephrine intraoperatively in µg/kg/min.	Day 0
Quality of intraoperative anesthesia	Duration of surgery (time between entering the operating room and leaving the room) in minutes.	Day 0
Ileus Postoperative	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)	Day 4
Duration of hospitalization	Length of hospitalization (Time between arrival at the hospital and discharge) in days.	Day 10
Chronic neuropathic pain	Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)	Month-3
Long-term morphine consumption	Morphine consumption at 3-month (yes/no)	Month-3
Physical form recovery	Time between surgery and resumption of physical activity in days.	Month-3

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Julien CADIET, PH, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Pain; Thoracic surgery; Opioid Free Anesthesia; Video-thoracoscopy
• Other Study ID Numbers: RC22_0112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No