ThoracicVATOFANCT04246099
Opioid-free Anesthesia in Thoracic Surgery
An observational study of Thoracic and Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
No study has been conducted to demonstrate the feasibility and safety of an Opioid-Free Anesthesia (OFA) protocol compared to Opioid-Based Anesthesia (OBA) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Post-operative care
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 1 Nov 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy in Department of Anesthesiology and Intensive Care at Louis Pradel University Hospital. If patient benefit of the OFA protocol, he was part of the group OFA (opioid free anesthesia) If patient don't benefit of the OFA protocol, he was part of the group OBA (opioid based anesthesia)
Who may be able to join
- All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
- Opioid Free Anesthesia (OFA) administration was left to the discretion of the attending anesthetist according to his or her practices and habits.
- age 18 or over
- lobectomy or wedge resection by Video-Assisted Thoracoscopy Surgery (VATS)
Who cannot join
- toxicomania,
- epidural analgesia use,
- thoracotomy conversion
- Patient-Controlled Analgesia with morphine (PCA)
- Patient who object to take part of the study.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology and Intensive Care - Louis Pradel University Hospital - Hospices Civils, Lyon, France
Bron, 69500
About this study
Official title: Effect of Opioid-free Anesthesia on Perioperative Period After Video-assisted Thoracoscopic Lobectomy: a Retrospective Study
No study has been conducted to demonstrate the feasibility and safety of an Opioid-Free Anesthesia (OFA) protocol compared to Opioid-Based Anesthesia (OBA) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. The aim of the present study was to evaluate the effect of OFA on post-operative opioids consumption, pain and the post-operative period after lobectomy by Video-Assisted Thoracoscopy Surgery (VATS). systems.
Investigators perform a retrospective, single-center study in 2019. Patients were divided into two groups: OFA (with dexmedetomidine) or OBA (sufentanyl).
Read more
Investigators analyse the total postoperative opioid consumption in the 48 h after surgery. Investigators asses pain intensity in the 48 h after surgery, operative hemodynamic stability, Post-Operative Pain (POP) in Post-Anesthesia Care Unit (PACU) and POP on day 30.
All data are available in the medical record
Hypothesis: OFA can reduce post-operative opioids consumption, pain in lobectomy by video-assisted thoracoscopy surgery (VATS).
- Being tested
- Post-operative care
- Keywords
- Post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative careOther
Retrospective collection of clinical data recorded in the electronic medical record.
The following variables were continuously recorded in the institutional database: age, gender, body weight, height, personal medical history, American Society of Anesthesiologists (ASA) score, type of thoracic surgery, the duration of surgery, duration of anesthesia (from intubation to extubation), the duration of PACU stay, the need for morphine titration, epinephrine, norepinephrine.
For data at day 30, the vast majority of patients were included in the enhanced recovery program and as such benefited from a consultation at 1 month with a coordination nurse who collected data on post-operative pain in a standardized manner.
All data was extracted from investigators institutional database and collected by a physician who was not involved in the care of the study patients.
| Study group | Role | What they receive |
|---|---|---|
| Group opioid free anesthesia | Patient benefit of the opioid free anesthesia protocol Receives: Other: Post-operative care | |
| Group opioid based anesthesia | Patient don't benefit of the opioid free anesthesia protocol Receives: Other: Post-operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dose of postoperative opioid
The primary endpoint was the cumulative dose of postoperative opioid in the first 48 h (D2) (in milligrams of oral morphine equivalent) which included morphine and tramadol after conversion (1mg of intra-veinous morphine = 3 mg of oral morphine, and 10 mg of oral morphine = 50 mg of oral tramadol)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246099
- Sponsor's protocol ID
- VATOFA
- Acronym
- VATOFA
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 31 Jan 2020
- 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 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid-free Anesthesia on Perioperative Period After Video-assisted Thoracoscopic Lobectomy: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04246099
- Acronym / sponsor ID
- VATOFA / VATOFA
- Keywords
- Post-operative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 29 Jan 2020 (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.
No study has been conducted to demonstrate the feasibility and safety of an Opioid-Free Anesthesia (OFA) protocol compared to Opioid-Based Anesthesia (OBA) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. The aim of the present study was to evaluate the effect of OFA on post-operative opioids consumption, pain and the post-operative period after lobectomy by Video-Assisted Thoracoscopy Surgery (VATS). systems.
Investigators perform a retrospective, single-center study in 2019. Patients were divided into two groups: OFA (with dexmedetomidine) or OBA (sufentanyl).
Investigators analyse the total postoperative opioid consumption in the 48 h after surgery. Investigators asses pain intensity in the 48 h after surgery, operative hemodynamic stability, Post-Operative Pain (POP) in Post-Anesthesia Care Unit (PACU) and POP on day 30.
All data are available in the medical record
Hypothesis: OFA can reduce post-operative opioids consumption, pain in lobectomy by video-assisted thoracoscopy surgery (VATS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group opioid free anesthesia | – | Other: Post-operative carePatient benefit of the opioid free anesthesia protocol |
| Group opioid based anesthesia | – | Other: Post-operative carePatient don't benefit of the opioid free anesthesia protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy in Department of Anesthesiology and Intensive Care at Louis Pradel University Hospital. If patient benefit of the OFA protocol, he was part of the group OFA (opioid free anesthesia) If patient don't benefit of the OFA protocol, he was part of the group OBA (opioid based anesthesia)
Key inclusion criteria (4 listed)
- All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
- Opioid Free Anesthesia (OFA) administration was left to the discretion of the attending anesthetist according to his or her practices and habits.
- age 18 or over
- lobectomy or wedge resection by Video-Assisted Thoracoscopy Surgery (VATS)
Key exclusion criteria (5 listed)
- toxicomania,
- epidural analgesia use,
- thoracotomy conversion
- Patient-Controlled Analgesia with morphine (PCA)
- Patient who object to take part of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-operative careRetrospective collection of clinical data recorded in the electronic medical record. The following variables were continuously recorded in the institutional database: age, gender, body weight, height, personal medical history, American Society of Anesthesiologists (ASA) score, type of thoracic surgery, the duration of surgery, duration of anesthesia (from intubation to extubation), the duration of PACU stay, the need for morphine titration, epinephrine, norepinephrine. For data at day 30, the vast majority of patients were included in the enhanced recovery program and as such benefited from a consultation at 1 month with a coordination nurse who collected data on post-operative pain in a standardized manner. All data was extracted from investigators institutional database and collected by a physician who was not involved in the care of the study patients. | Other | Group opioid based anesthesia, Group opioid free anesthesia |
Primary outcome
Cumulative dose of postoperative opioid
Time frame: 48 hours
The primary endpoint was the cumulative dose of postoperative opioid in the first 48 h (D2) (in milligrams of oral morphine equivalent) which included morphine and tramadol after conversion (1mg of intra-veinous morphine = 3 mg of oral morphine, and 10 mg of oral morphine = 50 mg of oral tramadol)
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 31 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thoracic and Surgery, run by Hospices Civils de Lyon 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 4 inclusion and 5 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 31 Jan 2020. 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?
Cumulative dose of postoperative opioid (time frame: 48 hours). 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 31 Jan 2020.