An interventional study of Laryngeal Mask Airway and Thoracic Paravertebral Block with Local Anesthetic in Pulmonary Nodules, Early Stage Lung Cancer (I and II) and Thoracoscopic Surgery, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
This is a prospective, randomized controlled clinical trial conducted at a single center. The study aims to evaluate whether a "tubeless" strategy can enhance recovery for patients undergoing minimally invasive thoracoscopic sublobar resection (wedge or segment resection) for small lung nodules.
Participants will be randomly assigned to one of two groups:
The main goal is to compare the rate of achieving high-quality fast-track recovery at 24 hours after surgery between the two groups. This study will provide evidence on whether the tubeless approach can help patients recover faster and more comfortably without compromising safety.
This is a prospective, open-label, randomized controlled trial with a 1:1 allocation ratio. Adult patients (aged 18-75) scheduled for uniportal VATS sublobar resection for peripheral lung nodules (≤2 cm, ≤2 cm from the pleura) will be assessed for eligibility. Key exclusion criteria include severe pleural adhesions, inability to achieve selective lung ventilation, and severe cardiopulmonary dysfunction.
The primary outcome is a composite endpoint measuring the rate of high-quality fast-track recovery at 24 hours postoperatively, defined as simultaneously meeting all three criteria: 1) meeting standardized discharge criteria, 2) a QoR-15 (Quality of Recovery-15) score ≥130, and 3) absence of Clavien-Dindo grade ≥II respiratory adverse events until the first follow-up.
Secondary outcomes include individual components of the primary endpoint, pneumothorax rate, postoperative pain scores, time to first ambulation, length of hospital stay, hospitalization costs, and patient satisfaction. A sample size of 138 participants (69 per group) was calculated to provide sufficient statistical power. Data analysis will follow the intention-to-treat principle.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 138 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 167 studies on the registry; 69 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm receive the tubeless strategy: * Anesthesia: Laryngeal mask airway with spontaneous ventilation (non-intubated). * Drainage: No chest tube placement after surgery * Goal: To enhance recovery by minimizing invasive procedures.
Device: Laryngeal Mask Airway · Drug: Thoracic Paravertebral Block with Local Anesthetic · Procedure: Non-intubated Anesthesia
Participants in this arm receive the conventional standard care: * Anesthesia: Double-lumen endotracheal intubation with mechanical ventilation. * Drainage: Routine chest tube drainage with water-seal suction postoperatively. * Follows current clinical guidelines for thoracoscopic sublobar resection.
Device: Double-lumen Endotracheal Tube · Device: Chest Tube Drainage
Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
General anesthesia with spontaneous ventilation without endotracheal intubation.
Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.
24-hour high-quality recovery rate
Composite endpoint defined as meeting all of the following criteria at 24 hours postoperatively: (1) meeting standardized discharge criteria (stable vital signs, controlled pain, autonomous ambulation); (2) Quality of Recovery-15 (QoR-15) score ≥130 (range 0-150; higher scores indicate better recovery); and (3) absence of Clavien-Dindo grade ≥II respiratory complications.
Time frame: 24 hours after surgery
Postoperative complications (Clavien-Dindo classification)
Incidence and severity of postoperative complications classified according to the Clavien-Dindo classification, including pneumothorax, atelectasis, and pleural effusion requiring intervention.
Time frame: From surgery until 30 days after discharge
Plan to share: Yes — The de-identified individual participant data that underlie the results reported in the primary publication of this trial will be shared. This includes baseline characteristics (age, gender, BMI), intraoperative data (operation time, blood loss), and primary and secondary outcome data (e.g., QoR-15 scores, pneumothorax rates, length of stay, complication rates).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The IPD and supporting documents will become available within 6 months after the publication of the primary trial results. The data will be accessible for a minimum of 5 years.
Access criteria: The IPD will be accessible to researchers who provide a methodologically sound research proposal approved by an independent review committee. Proposals should be directed to the corresponding author. Data will be shared for the purpose of achieving the approved research aims. A data access agreement must be signed before data release.
Start is estimated for Feb 2026; primary completion for Jun 2026, 4 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University →