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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Not yet enrolling; Phase 4

Conditions: Pain Management

Treatments: Drug: Bupivacaine 0.25%; Drug: Normal Saline; Other: Multimodal Analgesia; Drug: Bupivacaine 0.125%

Study type: Interventional

Funder types: Other

Identifiers

NCT07393386

IDLJ-20251125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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249 participants in 3 patient groups, including a placebo group

0.25% Bupivacaine Intrapleural Analgesia

Experimental group

Description:

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.

Treatment:

Other: Multimodal Analgesia

Drug: Bupivacaine 0.25%

0.125% Bupivacaine Intrapleural Analgesia

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine 0.125%

Other: Multimodal Analgesia

Placebo Intrapleural Analgesia (Normal Saline)

Placebo Comparator group

Description:

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.

Treatment:

Other: Multimodal Analgesia

Drug: Normal Saline