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Opioid-free Anesthesia and Thoracoscopy Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05308355
Acronym
OFAT
Enrollment
90
Registered
2022-04-04
Start date
2022-04-04
Completion date
2023-04-30
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Free Anesthesia, Thoracic Surgery

Keywords

Video-thoracoscopy, Chronic Pain, Opioid Free Anesthesia, Thoracic surgery

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.

Interventions

None listed

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumptionDay 2Total morphine consumption over the first 48 post operative hours in milligrammes

Secondary

MeasureTime frameDescription
Quality of intraoperative anesthesiaDay 0Duration of surgery (time between entering the operating room and leaving the room) in minutes.
Ileus PostoperativeDay 4Presence 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 hospitalizationDay 10Length of hospitalization (Time between arrival at the hospital and discharge) in days.
Preoperatory haemodynamic toleranceDay 0Maximum doses of norepinephrine intraoperatively in µg/kg/min.
Long-term morphine consumptionMonth-3Morphine consumption at 3-month (yes/no)
Physical form recoveryMonth-3Time between surgery and resumption of physical activity in days.
Chronic neuropathic painMonth-3Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026