2025-524240-35-00招募中4 期
OFA-VATS : Impact of opioid free anesthesia on postoperative quality of recovery and analgesia after video or robot assisted thoracic surgery
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 5
- 主要终点
- Score obtained from the self-administered QoR-15 questionnaire at D1 after surgery. The questionnaire will be completed by the patient while blinded to the treatment group
研究概览
简要总结
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Score obtained from the self-administered QoR-15 questionnaire at D1 after surgery. The questionnaire will be completed by the patient while blinded to the treatment group
Score obtained from the self-administered QoR-15 questionnaire at D1 after surgery. The questionnaire will be completed by the patient while blinded to the treatment group
次要结局
- QoR-15 self-administered questionnaire score on postoperative day 0 (POD0) and postoperative day 1 (POD1)
- Pain assessed using a standard Numeric Rating Scale (NRS) at rest and during coughing on POD0 (post-intervention), POD1, and POD2
- Total dose of morphine administered postoperatively up to POD2
- Number of episodes of postoperative nausea and vomiting (PONV) requiring treatment up to POD2. Time to return of bowel function (first postoperative flatus), censored at POD2. Occurrence of postoperative cognitive dysfunction assessed on POD1 using the CAM (Confusion Assessment Method) or CAM-ICU validated in French.
- Occurrence of postoperative pulmonary complications according to the Melbourne Group Scale (≥4 of 8 criteria)) within 28 days after surgery
- Forced Expiratory Volume per second (FEV₁) measured preoperatively (day −1) and on POD1 using a portable electronic spirometer. Peak Expiratory Flow (PEF) measured preoperatively (day −1) and on POD1 using a portable electronic spirometer. Forced Vital Capacity (FVC) measured preoperatively (day −1) and on POD1 using a portable electronic spirometer Duration of postoperative oxygen therapy within the first 72 postoperative hours
- Time to first patient mobilization (ambulation), censored at 28 days
- Total length of hospital stay, censored at 28 days
- Mortality at POD28
- Number of patients with chronic pain at 6 months postoperatively, assessed using a simplified DN4 questionnaire by telephone interview (DN2). DN2 considered positive if ≥3 positive answers out of 7. DN4 questionnaire considered positive if ≥4 positive answers out of 10. Pain intensity assessed using the Numeric Rating Scale (NRS) at rest and during coughing at 6 months by telephone interview. Analgesic consumption, including opioids
- Occurrence of intraoperative cardiac events, including bradycardia (defined as episodes with heart rate <45 beats/min), hypotension (defined as mean arterial pressure <65 mmHg), and hypertension (defined as mean arterial pressure >90 mmHg)
研究者
Grégoire LE GAC
Scientific
Centre Hospitalier Universitaire De Rennes
研究点 (5)
Loading locations...
相似试验
尚未招募
不适用
The recovery in thyroid surgeries with two group of drugsCTRI/2025/07/091773IGIMS76
尚未招募
不适用
Quality of recovery in breast conservation surgery.CTRI/2025/09/094051Self funded120
招募中
3 期
COMPARISON OF THE EFFICACY OF OPIOID-FREE ANESTHESIA AND OPIOID-BASED ANESTHESIA IN FEMALE LAPAROSCOPIC STERILIZATIONCTRI/2025/05/086261Ikshit Singh62
尚未招募
不适用
Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic .NCT07306910Assiut University110
尚未招募
Phase 3 4
A study comparing opioid free and opioid based anaesthesia for recovery and Pain control after Gynecological cancer surgeryCTRI/2026/01/101040Self80