Intrapleural Bupivacaine Analgesia for Postoperative Pain Management After Minimally Invasive Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial

NCT07393386 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Phase

Phase 4

Started

2026-02-01

Last updated

2026-02-06

Condition(s) studied

Pain Management

Investigational drug(s) / intervention(s)

Bupivacaine 0.125%Bupivacaine 0.25%Normal SalineMultimodal Analgesia

Bupivacaine 0.125%: Bupivacaine 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%: Bupivacaine 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: Normal 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: All 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients scheduled for elective video-assisted thoracoscopic surgery 2. Age≥18 years 3. American Society of Anesthesiologists (ASA) physical status classification I-III Exclusion Criteria: 1. Pregnancy or breastfeeding 2. History of chronic pain 3. History of alcohol or opioid dependence 4. Significant cardiopulmonary dysfunction, including heart failure or severe cardiac conduction abnormalities 5. Coexisting central nervous system disorders 6. Hepatic or renal dysfunction 7. Known hypersensitivity to local anesthetics or opioids 8. Local infection at or near the planned site of regional anesthesia, or systemic infection 9. Language impairment or difficulty in communication 10. Refusal to participate in the study or refusal to use patient-controlled analgesia 11. Concurrent participation in another clinical trial

Primary outcome measure(s)

Area Under the Curve of Pain Intensity During Coughing — 1, 2, 6, 12, 24, 36, and 48 hours postoperatively
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.

Trial sites (1)

Facility	City	Region	Status
Shanghai Pulmonary Hospital	Shanghai	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07393386 on ClinicalTrials.gov ↗ ← All trials in China