Postoperative Pain Management on Patients Undergoing Video-assisted Thoracoscopic (VATS) Lung Tumor Resection: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. MMA can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. Inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.
详细描述
This prospective, observational study is planned to investigate the efficacy of different MMA regimens conducting in our hospital. Patients undergoing video-assisted thoracoscopic (VATS) lung tumor resection will be invited to participate in the study and grouped based on the MMA regimens. Anxiety, quality of recovery, pain intensity will be evaluated pre- and post-operatively. Demographic data, surgery record, medicine record and postoperative complications will be gained from medical history system and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •diagnosed as lung cancer.
- •planning to undergo primary, video-assisted thoracoscopic lung tumor resection.
- •American Society of Anesthesiology Physical Class 1~3.
排除标准
- •unable to take assessments of the endpoints.
- •having this surgery in an emergency.
- •surgery involving other orangs, such as esophagus and stomach.
- •severe abnormality of cardiac, hepatic, or renal function.
- •allergic to opioids.
- •allergic to NSAIDs.
- •diagnosed as chronic pain or chronic use of analgesics.
- •unsuitable for participation judged by investigator.
研究组 & 干预措施
NALDEBAIN
Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.
干预措施: Dinalbuphine sebacate (Drug)
NALDEBAIN
Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.
干预措施: Analgesic injectables (Drug)
NALDEBAIN
Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.
干预措施: Enteral analgesics (Drug)
CONTROL
Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group.
干预措施: Analgesic injectables (Drug)
CONTROL
Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group.
干预措施: Enteral analgesics (Drug)
结局指标
主要结局
Postoperative pain intensity
时间窗: Within 3 days after surgery
Pain intensity is assessed by numerical rating scale (NRS) daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated.
次要结局
- Consumption of analgesics(Within 7 days after surgery)
- GAD-7(At baseline, 7 days and 3 months after surgery)
- QoR-15(At baseline, 7 days and 3 months after surgery)
研究者
Hsin-Yuan Fang
Associate Director of China Medical University Hospital
China Medical University Hospital