Postoperative pain is common after video-assisted thoracoscopic surgery (VATS), with pleural irritation caused by chest tube placement being a major contributor. Inadequate pain control may impair respiratory function, delay postoperative recovery, and increase the risk of complications. However, effective and targeted analgesic strategies specifically addressing chest tube-related pain remain limited.
This is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial designed to evaluate the efficacy and safety of programmed intermittent intrapleural administration of bupivacaine at different concentrations for postoperative analgesia after VATS. A total of 249 patients undergoing VATS will be randomly assigned in a 1:1:1 ratio to receive intrapleural injections of 0.25% bupivacaine, 0.125% bupivacaine, or normal saline. The primary outcome is pain intensity during coughing within 48 hours after surgery. Secondary outcomes include pain intensity at rest, plasma bupivacaine concentrations, quality of postoperative recovery, cumulative opioid consumption, and postoperative inflammatory marker levels.
This study aims to provide evidence to inform analgesic strategies for chest tube-related pain following VATS and to clarify the optimal use and safety profile of intrapleural bupivacaine.
Patients scheduled for elective video-assisted thoracoscopic surgery
Age≥18 years
American Society of Anesthesiologists (ASA) physical status classification I-III
Pregnancy or breastfeeding
History of chronic pain
History of alcohol or opioid dependence
Significant cardiopulmonary dysfunction, including heart failure or severe cardiac conduction abnormalities
Parallel
Bupivacaine 0.125%
DrugBupivacaine 0.125% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery.
Bupivacaine 0.25%
DrugBupivacaine 0.25% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery.
Normal Saline
DrugNormal saline is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery.
Multimodal Analgesia
Other interventionAll participants receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated, in addition to the assigned intrapleural intervention.
Area Under the Curve of Pain Intensity During Coughing
Pain intensity during coughing will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated measurements to reflect overall pain burden during the first 48 hours after surgery. Pain assessments will be performed by trained study evaluators.
Area Under the Curve of Resting Pain Intensity
Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated assessments to evaluate cumulative resting pain during the first 48 hours after surgery. Assessments will be performed by trained study evaluators.
Postoperative Opioid Consumption
Total opioid consumption within the first 48 hours after surgery will be recorded and analyzed.
Quality of Recovery
Postoperative recovery quality will be assessed using the 40-item Quality of Recovery questionnaire (QoR-40), which evaluates multiple domains of postoperative recovery.
Plasma Bupivacaine Concentration
Plasma concentrations of bupivacaine will be measured to assess systemic exposure following intrapleural administration. Venous blood samples will be collected at predefined time points and analyzed using validated analytical methods. Concentration-time data will be used to characterize the pharmacokinetic profile.
Patient Satisfaction With Pain Management
Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied), reflecting overall satisfaction with pain control.
Rescue Analgesic Consumption
Total consumption of rescue analgesic medications administered within the first 48 hours after surgery will be recorded and analyzed.
Postoperative Systemic Inflammatory Response
The postoperative systemic inflammatory response will be assessed as a composite evaluation based on venous blood samples. This assessment will characterize the overall inflammatory response by integrating multiple inflammatory components, including serum cytokine levels (IL-6, IL-8, IL-12, TNF-α), C-reactive protein (CRP), and cellular inflammation indices derived from complete blood count data, including the systemic immune-inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR).
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