Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Postoperative Quality of Recovery in Patients Undergoing Video-assisted Thoracoscopic Partial Pneumonectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Postoperative Quality of Recovery at 24 hours
研究概览
简要总结
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive approach for partial pneumonectomy, but postoperative pain remains a major challenge affecting recovery. Intercostal nerve block (ICNB) with conventional local anesthetics provides limited duration of analgesia, often insufficient to cover the peak pain period after surgery. Liposomal bupivacaine is a long-acting formulation designed to provide extended analgesia up to 72 hours. This study aims to evaluate the effect of preoperative ICNB with liposomal bupivacaine compared with conventional bupivacaine hydrochloride on postoperative quality of recovery in patients undergoing VATS partial pneumonectomy. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively. We hypothesize that liposomal bupivacaine ICNB results in superior recovery quality compared with conventional bupivacaine, with reduced postoperative pain and opioid consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for thoracic surgery under general anesthesia via thoracoscopic approach;
- •Age 18-65 years;
- •Classified as Grade I-II by the American Society of Anesthesiologists (ASA).
排除标准
- •History of local anesthetic allergy.
- •Chronic opioid users.
- •Contraindications for nerve block, including infection at the puncture site and coagulation disorders;
- •Language communication impairment.
- •Other conditions unsuitable for inclusion in the trial.
研究组 & 干预措施
Control group
30 mL of 0.25% bupivacaine hydrochloride was administered by the surgeon under thoracoscopy to perform intercostal nerve block at the 3rd to 8th intercostal spaces, with 5 mL injected into each intercostal space prior to the start of the procedure.
干预措施: Bupivacaine Hydrochloride (Drug)
Liposome bupivacaine group
A 30 mL solution was prepared by diluting 15 mL of bupivacaine liposome with 15 mL of 0.9% sodium chloride. Prior to the procedure, the surgeon performed intercostal nerve blockage at the 3rd to 8th intercostal spaces under thoracoscopy, injecting 5 mL into each intercostal space.
干预措施: Bupivacaine liposome (Drug)
结局指标
主要结局
Postoperative Quality of Recovery at 24 hours
时间窗: 24 hours after surgery
Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery.
次要结局
- Postoperative Quality of Recovery at 48 hours(48 hours after surgery)
- Area Under the Curve (AUC) of Pain Scores in the First 48 Hours(From PACU arrival to 48 hours post-PACU arrival (assessed at 8 time points))
- Cumulative Morphine Consumption in the First 48 Hours(First 48 hours after surgery)
- Time to First PCA Demand(Up to 48 hours)
- Patient Satisfaction(48 hours after surgery)
- Duration of PACU Stay(From PACU arrival to Aldrete score ≥9, up to 1 hour)
- Emergence time(Up to 1 hour)
- Intraoperative Remifentanil Consumption(Intraoperative period (from anesthesia maintenance initiation to end of surgery))
研究者
Lin Huifen
Associate Professor of Anesthesiology
Sanming First Hospital