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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.
• Другое 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.

Первичные конечные точки

• Area Under the Curve of Pain Intensity During Coughing [Срок оценки: 1, 2, 6, 12, 24, 36, and 48 hours postoperatively]

Вторичные конечные точки (3)

• Area Under the Curve of Resting Pain Intensity [Срок оценки: 1, 2, 6, 12, 24, 36, and 48 hours postoperatively]
• Postoperative Opioid Consumption [Срок оценки: Up to 48 hours postoperatively]
• Quality of Recovery [Срок оценки: Baseline (preoperative), 24 hours, and 48 hours postoperatively]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT07393386 · IDLJ-20251125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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