NCT05742256尚未招募1 期
Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery
Qianfoshan Hospital0 个研究点目标入组 159 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 159
- 主要终点
- The main indicators were NRS scores at rest and cough at 24 h postoperatively.
研究概览
简要总结
In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age > 60 years
- •Patients undergoing thoracoscopic lobectomy
- •ASA (American Academy of Anesthesiologists) Grades I-III
- •There were no obvious abnormalities in heart, liver, and kidney function
- •Sign the informed consent form for this clinical study
排除标准
- •History of oxycodone or sufentanil allergy
- •Renal or hepatic dysfunction
- •History of drug or alcohol abuse
- •Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis
- •Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases.
- •People with head trauma or other brain diseases -
研究组 & 干预措施
Test group 1(OCA group)
Experimental
干预措施: Oxycodone 1mg/kg (Drug)
Test group 2(OCB group)
Experimental
干预措施: Oxycodone 1.5mg/kg (Drug)
Control group(SF group)
Active Comparator
干预措施: Sufentanil (Drug)
结局指标
主要结局
The main indicators were NRS scores at rest and cough at 24 h postoperatively.
时间窗: at 24h after surgery
NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.
次要结局
- Time to double-lumen tracheal extraction(Within two hours after surgery)
- NRS score at rest and cough(at 2h , 4h, 12h, 48h after surgery)
- sedation score (Ramsay sedation score)(at 2 h , 4 h , 12 h ,24 h,48 h postoperatively)
- sufentanil consumption(Within 48 hours after surgery)
- oxycodone consumption(Within 48 hours after surgery)
- analgesic pump compressions(Within 48 hours after surgery)
- additional analgesic doses(Within 48 hours after surgery)
- incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin(Within 48 hours after surgery)
- gastrointestinal recovery (exhaust time)(Within 48 hours after surgery)
- laboratory results of C-reactive protein 1 day before and after surgery(Within 48 hours after surgery)
- laboratory results of interleukin-6 laboratory test 1 day before and after surgery(Within 48 hours after surgery)
研究者
Pengcai Shi
Chief physician，Master Tutor
Qianfoshan Hospital
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