Authorised Phase III and phase IV (Integrated) indication for pulmonary resection surgery (segmentectomy or lobectomy)

OFA-VATS : Impact of opioid free anesthesia on postoperative quality of recovery and analgesia after video or robot assisted thoracic surgery

EU CTIS ID: 2025-524240-35-00

What this study is testing

To compare the effect, in terms of patient-reported quality of recovery on postoperative day 1, of an opioid-free anaesthesia (OFA) protocol versus a standard opioid-based intraoperative protocol in video-assisted (VATS) or robot-assisted thoracic surgery (RATS).

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Adult patient (≥18 years)
  • Indication for pulmonary resection surgery (segmentectomy or lobectomy) performed by video-assisted thoracoscopy or scheduled robot-assisted surgery
  • Use of effective contraception in accordance with CFTG recommendations
  • Having received oral and written information about the study protocol and having provided written informed consent to participate in the research
  • Affiliation with a social security health insurance system

You likely can't join if

  • Emergency surgery
  • Epilepsy not controlled by medical treatment
  • Decompensated respiratory failure (in the absence of mechanical ventilation)
  • Heart failure with left ventricular ejection fraction (LVEF) <40%
  • Obstructive sleep apnea syndrome
  • Concomitant use of buprenorphine, nalbuphine, pentazocine, or naltrexone
See the full eligibility criteria
Who can join
  • Adult patient (≥18 years)
  • Indication for pulmonary resection surgery (segmentectomy or lobectomy) performed by video-assisted thoracoscopy or scheduled robot-assisted surgery
  • Use of effective contraception in accordance with CFTG recommendations
  • Having received oral and written information about the study protocol and having provided written informed consent to participate in the research
  • Affiliation with a social security health insurance system
What rules you out
  • Emergency surgery
  • Epilepsy not controlled by medical treatment
  • Decompensated respiratory failure (in the absence of mechanical ventilation)
  • Heart failure with left ventricular ejection fraction (LVEF) <40%
  • Obstructive sleep apnea syndrome
  • Concomitant use of buprenorphine, nalbuphine, pentazocine, or naltrexone
  • Preoperative prescription of opioids
  • Bradycardia <40 beats/min
  • Uncontrolled hypotension or shock state
  • Other contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including: o Active gastroduodenal ulcer; o History of peptic ulcer disease or recurrent gastrointestinal bleeding (at least two documented episodes); o History of gastrointestinal bleeding or perforation associated with NSAID use.
  • Inability to complete the QoR-15 questionnaire
  • Combined surgery
  • Adults under legal protection (judicial safeguard, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors, and persons unable to provide informed consent
  • High risk of conversion to thoracotomy
  • Severe hepatic failure
  • Acute porphyria
  • Hypersensitivity to any of the active substances used for anaesthesia or to any excipient
  • Atrioventricular conduction disorders requiring permanent cardiac pacing that has not yet been performed
  • Adams–Stokes syndrome
  • Acute cerebrovascular disease, traumatic brain injury, or intracranial hypertension in the absence of controlled ventilation

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.