Opioid-free Anesthesia and Thoracoscopy Surgery

Thoracic Surgery Clinical Trial

— OFAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308355
• Other study ID #: RC22_0112
• Status: Completed
• Start date: April 4, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Free Anesthesia
• Thoracic Surgery

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Total morphine consumption over the first 48 post operative hours in milligrammes	Day 2
Secondary	Preoperatory haemodynamic tolerance	Maximum doses of norepinephrine intraoperatively in µg/kg/min.	Day 0
Secondary	Quality of intraoperative anesthesia	Duration of surgery (time between entering the operating room and leaving the room) in minutes.	Day 0
Secondary	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
Secondary	Duration of hospitalization	Length of hospitalization (Time between arrival at the hospital and discharge) in days.	Day 10
Secondary	Chronic neuropathic pain	Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)	Month-3
Secondary	Long-term morphine consumption	Morphine consumption at 3-month (yes/no)	Month-3
Secondary	Physical form recovery	Time between surgery and resumption of physical activity in days.	Month-3