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Not yet recruiting NCT07393386

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

Phase IV Interventional Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine 0.125%, Bupivacaine 0.25%, Normal Saline, Multimodal Analgesia.
Who it may be relevant to
Registry conditions: Pain Management. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • 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.
  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Area Under the Curve of Pain Intensity During Coughing [Time frame: 1, 2, 6, 12, 24, 36, and 48 hours postoperatively]
Secondary outcome measures (3)
  • Area Under the Curve of Resting Pain Intensity [Time frame: 1, 2, 6, 12, 24, 36, and 48 hours postoperatively]
  • Postoperative Opioid Consumption [Time frame: Up to 48 hours postoperatively]
  • Quality of Recovery [Time frame: Baseline (preoperative), 24 hours, and 48 hours postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT07393386 · IDLJ-20251125

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗