Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07393386

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for elective video-assisted thoracoscopic surgery
  • Age≥18 years
  • American Society of Anesthesiologists (ASA) physical status classification I-III

Exclusion criteria

  • Pregnancy or breastfeeding
  • History of chronic pain
  • History of alcohol or opioid dependence
  • Significant cardiopulmonary dysfunction, including heart failure or severe cardiac conduction abnormalities
  • Coexisting central nervous system disorders
  • Hepatic or renal dysfunction
  • Known hypersensitivity to local anesthetics or opioids
  • Local infection at or near the planned site of regional anesthesia, or systemic infection
  • Language impairment or difficulty in communication
  • Refusal to participate in the study or refusal to use patient-controlled analgesia
  • Concurrent participation in another clinical trial

Treatment and study plan

Bupivacaine 0.125%

Drug

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%

Drug

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

Drug

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

Other

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.

Primary outcomes

  1. Area Under the Curve of Pain Intensity During Coughing

    Time frame: 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.

Secondary outcomes

  1. Area Under the Curve of Resting Pain Intensity

    Time frame: 1, 2, 6, 12, 24, 36, and 48 hours postoperatively

    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.

  2. Postoperative Opioid Consumption

    Time frame: Up to 48 hours postoperatively

    Total opioid consumption within the first 48 hours after surgery will be recorded and analyzed.

  3. Quality of Recovery

    Time frame: Baseline (preoperative), 24 hours, and 48 hours postoperatively

    Postoperative recovery quality will be assessed using the 40-item Quality of Recovery questionnaire (QoR-40), which evaluates multiple domains of postoperative recovery.

Other outcomes

  1. Plasma Bupivacaine Concentration

    Time frame: From pre-administration to 48 hours postoperatively

    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.

  2. Patient Satisfaction With Pain Management

    Time frame: 48 hours postoperatively

    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.

  3. Rescue Analgesic Consumption

    Time frame: Up to 48 hours postoperatively

    Total consumption of rescue analgesic medications administered within the first 48 hours after surgery will be recorded and analyzed.

  4. Postoperative Systemic Inflammatory Response

    Time frame: Baseline (preoperative) and 24 hours postoperatively

    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).

  5. Adverse Events

    Time frame: From informed consent to hospital discharge (serious adverse events followed up to 30 days post-discharge)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leo Li

CONTACT

[email protected]

021-18621710790

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Acronym: IBVATS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.