Intrapleural Bupivacaine Analgesia for Postoperative Pain Management After Minimally Invasive Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Area Under the Curve of Pain Intensity During Coughing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective video-assisted thoracoscopic surgery
- •Age≥18 years
- •American Society of Anesthesiologists (ASA) physical status classification I-III
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Bupivacaine 0.25% (Drug)
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.
干预措施: Multimodal Analgesia (Other)
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.
干预措施: Bupivacaine 0.125% (Drug)
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.
干预措施: Multimodal Analgesia (Other)
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.
干预措施: Normal Saline (Drug)
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.
干预措施: Multimodal Analgesia (Other)
结局指标
主要结局
Area Under the Curve of Pain Intensity During Coughing
时间窗: 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.
次要结局
- Area Under the Curve of Resting Pain Intensity(1, 2, 6, 12, 24, 36, and 48 hours postoperatively)
- Postoperative Opioid Consumption(Up to 48 hours postoperatively)
- Quality of Recovery(Baseline (preoperative), 24 hours, and 48 hours postoperatively)
研究者
Wei Wu
Attending Physician, Department of Anesthesiology
Shanghai Pulmonary Hospital, Shanghai, China