Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy
- Conditions
- Postoperative Pain
- Registration Number
- NCT06570538
- Lead Sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 140
<br><br> - Aged between 18 and 65 years.<br><br> - Patients with lung cancer or suspected lung cancer who are undergoing lobectomy<br> surgery via Video-assisted thoracoscopic surgery (VATS) or Robotic-assisted<br> thoracoscopic surgery (RATS).<br><br> - American anesthesiologist association (ASA) physical status classification?-?.<br><br> - Surgery is expected to last at least 2 hours, with a minimum of 2 days of<br> postoperative hospitalization.<br><br> - Patients participate voluntarily and have signed an informed consent form.<br><br>Exclusion Criteria:<br><br> - Patients who underwent open-heart surgery.<br><br> - Patients with BMI =30 kg/m², or =18.5 kg/m².<br><br> - Patients who are allergic to any of the local anesthetic drugs, such as ropivacaine,<br> lidocaine, bupivacaine, procaine, bupivacaine, benzocaine, dacronin, etc.<br><br> - Patients who are allergic to any of the general anesthesia drugs, such as those<br> including propofol, sufentanil, remifentanil, etc.<br><br> - Patients who currently have active ulcers or have gastrointestinal bleeding or who<br> are allergic to any NSAIDs such as parecoxib sodium, flurbiprofenol ester, and<br> acetaminophen.<br><br> - Patients with contraindications to epidural spinal plane block (ESPB), such as skin<br> infection near the puncture site or coagulation disorders.<br><br> - Patients allergic to ultrasound gel.<br><br> - Patients with significant preoperative renal insufficiency (creatinine more than<br> twice the upper limit of normal).<br><br> - Patients with severe spinal deformities prior to surgery.<br><br> - Patients with preoperative distant tumor metastasis.<br><br> - Patients who have experienced cardiovascular or cerebrovascular accidents within the<br> past six months.<br><br> - Patients with unstable angina, ischemic myocardial infarction, or heart failure in<br> the last six months.<br><br> - Patients with severe preoperative lung disease (such as pulmonary fibrosis, severe<br> lung abscess, pulmonary heart disease; or with FEV1 less than 50% of the predicted<br> value, PaO2 = 60 mmHg, PaCO2 > 50 mmHg).<br><br> - Patients with poorly controlled preoperative hypertension or diabetes mellitus.<br><br> - Patients with a past history of dementia, psychosis, or other neurological<br> disorders.<br><br> - Patients undergoing concurrent treatment for other surgical conditions.<br><br> - Patients taking sedatives, antidepressants, or hormonal medications.<br><br> - Patients with chronic pain, alcoholism, or drug dependence.<br><br> - Patients who are pregnant or breastfeeding<br><br> - Patients with other potentially serious medical conditions.<br><br> - Patients who are unable to understand Mandarin or Cantonese.<br><br> - Patients who participated in other clinical trials in the past 3 months<br><br> - Patients who refuse to participate in the study or sign the informed consent form.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative 48-h analgesic efficacy at cough
- Secondary Outcome Measures
Name Time Method Postoperative 48-h analgesic efficacy at rest;Postoperative quality of recovery;Postoperative pulmonary complications;The 48-hour postoperative rescue analgesia rate;Postoperative analgesic failure;Patient satisfaction with postoperative pain ratings;Time to resume;The incidence of unplanned ICU admission and reoperation;The 30d- and 90d- mortality;Related Adverse Events