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Completed

NCT Number: NCT05308355

Opioid-free Anesthesia and Thoracoscopy 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Morphine consumption

    Time frame: Day 2

    Total morphine consumption over the first 48 post operative hours in milligrammes

Secondary outcomes

  1. Preoperatory haemodynamic tolerance

    Time frame: Day 0

    Maximum doses of norepinephrine intraoperatively in µg/kg/min.

  2. Quality of intraoperative anesthesia

    Time frame: Day 0

    Duration of surgery (time between entering the operating room and leaving the room) in minutes.

  3. Ileus Postoperative

    Time frame: 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)

  4. Duration of hospitalization

    Time frame: Day 10

    Length of hospitalization (Time between arrival at the hospital and discharge) in days.

  5. Chronic neuropathic pain

    Time frame: Month-3

    Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)

  6. Long-term morphine consumption

    Time frame: Month-3

    Morphine consumption at 3-month (yes/no)

  7. Physical form recovery

    Time frame: Month-3

    Time between surgery and resumption of physical activity in days.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: OFAT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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