Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
90 participants
OBSERVATIONAL
2022-04-04
2023-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
OFA in Thoracic Surgery
NCT05063396
Opioid-free Anesthesia in Thoracic Surgery
NCT04246099
Opioid-free Anesthesia in VATS Lung Resection
NCT04507165
The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia
NCT05510986
Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
NCT05172739
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
OBA : Opioid Based Anesthesia
Conventional anesthesia with Propofol and Sufentanil boli with the possibility of regional loco anesthesia.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julien CADIET, PH
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Nantes
Nantes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC22_0112
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.