Opioid Free AnesthesiaOFATNCT05308355
Opioid-free Anesthesia and Thoracoscopy Surgery
An observational study of Opioid Free Anesthesia and Thoracic Surgery, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid Free Anesthesia, Thoracic Surgery
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Adult patient
- Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Free Anesthesia, Thoracic Surgery
- Keywords
- Video-thoracoscopy, Chronic Pain, Opioid Free Anesthesia, Thoracic surgery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Total morphine consumption over the first 48 post operative hours in milligrammes
Measured: Day 2
Secondary outcomes (7)
Preoperatory haemodynamic tolerance
Maximum doses of norepinephrine intraoperatively in µg/kg/min.
Measured: Day 0
Quality of intraoperative anesthesia
Duration of surgery (time between entering the operating room and leaving the room) in minutes.
Measured: 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)
Measured: Day 4
Duration of hospitalization
Length of hospitalization (Time between arrival at the hospital and discharge) in days.
Measured: Day 10
Chronic neuropathic pain
Evaluation of neuropathic pain (assessed by the DN 4 score:diagnosis of neuropathic pain)
Measured: Month-3
Long-term morphine consumption
Morphine consumption at 3-month (yes/no)
Measured: Month-3
Physical form recovery
Time between surgery and resumption of physical activity in days.
Measured: Month-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start4 Apr 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien CADIET, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308355
- Sponsor's protocol ID
- RC22_0112
- Acronym
- OFAT
- Status last verified
- Sep 2023
- First submitted
- 15 Feb 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an "Opioid Free Anesthesia" Protocol in Thoracoscopic Carcinological Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05308355
- Acronym / sponsor ID
- OFAT / RC22_0112
- Conditions
- Opioid Free Anesthesia, Thoracic Surgery
- Keywords
- Video-thoracoscopy, Chronic Pain, Opioid Free Anesthesia, Thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Adult patient
- Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morphine consumption
Time frame: Day 2
Total morphine consumption over the first 48 post operative hours in milligrammes
7 secondary outcomes
Preoperatory haemodynamic tolerance
Time frame: Day 0
Quality of intraoperative anesthesia
Time frame: Day 0
Ileus Postoperative
Time frame: Day 4
Duration of hospitalization
Time frame: Day 10
Chronic neuropathic pain
Time frame: Month-3
Long-term morphine consumption
Time frame: Month-3
Physical form recovery
Time frame: Month-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien CADIET, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Free Anesthesia and Thoracic Surgery, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.