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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management
• Intervention / Treatment: Drug: Bupivacaine 0.25%; Other: Multimodal Analgesia; Drug: Bupivacaine 0.125%; Drug: Normal Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 249
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Leo Li; Phone Number: 021-18621710790; Email: 18621710790@163.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Pulmonary Hospital
    • Contact: Leo Li; Phone Number: 021-18621710790; Email: 18621710790@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.25% Bupivacaine Intrapleural Analgesia; Participants receive programmed intermittent intrapleural administration of 0.25% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.	Drug: 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.; Other: 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.
Experimental: 0.125% Bupivacaine Intrapleural Analgesia; Participants receive programmed intermittent intrapleural administration of 0.125% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.	Other: 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.; Drug: 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.
Placebo Comparator: Placebo Intrapleural Analgesia (Normal Saline); Participants receive programmed intermittent intrapleural administration of normal saline via a chest drainage tube connected to a programmed infusion pump as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated.	Other: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 2, 6, 12, 24, 36, and 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 2, 6, 12, 24, 36, and 48 hours postoperatively
Postoperative Opioid Consumption	Total opioid consumption within the first 48 hours after surgery will be recorded and analyzed.	Up to 48 hours postoperatively
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.	Baseline (preoperative), 24 hours, and 48 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From pre-administration to 48 hours postoperatively
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.	48 hours postoperatively
Rescue Analgesic Consumption	Total consumption of rescue analgesic medications administered within the first 48 hours after surgery will be recorded and analyzed.	Up to 48 hours postoperatively
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).	Baseline (preoperative) and 24 hours postoperatively
Adverse Events	All adverse events will be recorded from the time of informed consent through hospital discharge. Adverse event severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, and events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 26.1. Serious adverse events will be followed until resolution, stabilization, or up to 30 days after hospital discharge, whichever occurs first.	From informed consent to hospital discharge (serious adverse events followed up to 30 days post-discharge)

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative pain; Thoracoscopic surgery; Intrapleural analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Agnosia; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: IDLJ-20251125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De identified individual participant data and related study documents (e.g., study protocol, statistical analysis plan) will be made available upon reasonable request after the completion of the study. Researchers interested in data access may submit a proposal to the principal investigator via email. The proposal should include a detailed research plan and data analysis proposal. Data will be provided following review and approval by the study team. Contact Email: 18621710790@163.com
• IPD Sharing Time Frame: Supporting documentation will be made available beginning 12 months after publication of the primary study results and will remain available for 5 years thereafter.
• IPD Sharing Access Criteria: De-identified individual participant data that underlie the results reported in the primary publication, as well as the study protocol and statistical analysis plan, will be available to qualified researchers. Requests must be submitted to the principal investigator and will be reviewed on a case-by-case basis. Access will be granted for scientifically sound proposals and subject to approval by the study team and the execution of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No