Effects of Continuous Lidocaine Infusion Via Closed Chest Drainage Tube on Postoperative Analgesia for Patients Undergoing Thoracoscopic Partial Lung Resection: a Single-center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- postoperative pain score（NRS）
研究概览
简要总结
The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are:
- To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy.
- Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery.
For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.
详细描述
At present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia.
The investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. In the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored.
In the protocol，participants will be randomized in a 1:1 ratio to the control or experimental groups. The experimental group received a continuous infusion of lidocaineThe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. The control group received only standard intravenous analgesia。In addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.
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
- None (Participant)
盲法说明
The study is open-label (unblinded). Because the IPCIL group required an additional intrapleural infusion pump that was not present in the control group, blinding of both participants and investigators was not feasible.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants ages 18-70 years.
- •participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery.
- •American Society of Anesthesiologists classification (ASA)I-III.
排除标准
- •severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III.
- •hypersensitivity to lidocaine,History of local anesthetic poisoning.
- •severe renal or hepatic dysfunction.
- •body mass index (BMI)>35 kg m-
- •severe pleural adhesions.
研究组 & 干预措施
Standard-dose sufentanil PCIA
Patients receive standard-dose sufentanil PCIA (2.0-2.5 µg/kg for 48 h) alone.
干预措施: Sufentanil (Drug)
Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA
Patients receive continuous intrapleural lidocaine infusion via the closed chest drainage tube (pulse 1 mL/30 min + continuous 2 mL/h) combined with reduced-dose sufentanil patient-controlled intravenous analgesia (PCIA, 1.0-1.5 µg/kg for 48 h).
干预措施: Lidocaine (Drug)
Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA
Patients receive continuous intrapleural lidocaine infusion via the closed chest drainage tube (pulse 1 mL/30 min + continuous 2 mL/h) combined with reduced-dose sufentanil patient-controlled intravenous analgesia (PCIA, 1.0-1.5 µg/kg for 48 h).
干预措施: Sufentanil (Drug)
结局指标
主要结局
postoperative pain score（NRS）
时间窗: Day 1
The primary outcome is the incidence of a numeric rating scale (NRS) pain score \> 3 on coughing/movement at 24 hours postoperatively (movement-evoked pain only).
次要结局
- the use of dolantin(Day 3)
- readmission rate(Month 1)
- interleukin-6(Day 1)
- postoperative delusion(Day 3)
- the use of opioids(Day 2)
- the amount of postoperative wound drainage(Day 3)
- C-reactive protein(Day 1)
- drainage extraction(up to 24 hours (before extubation))
- ICU stay time(From date of ICU admission until the date of leaving ICU, assessed up to 5 days.)
- healing rate of drainage wound(Day 21)
- the use of flurbiprofen axetil(Day 3)
- postoperative adverse events(Day 3)
- postoperative pulmonary complications(Day 3)
- Changes in postoperative pain(Day 2)
- hospital length of stay(From date of hospital admission until the date of discharge,assessed up to 15 days.)
研究者
Jinying Zhang
the attending doctor
Qilu Hospital of Shandong University