NCT02204878Unknown4 期
A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VAS scores change
研究概览
简要总结
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-70 years old;
- •Hepatic hemangioma patients who will undergo laparotomy surgery: diameter of hepatic hemangioma between 5-15cm, located in the right liver;
- •Child score 5-6;
- •BMI: 19-25;
- •ASA: Ⅰ ~ Ⅱ grade;
- •No comorbidities such as diabetes, hypertension, cardio renal or respiratory dysfunction, mental illness;
- •No known allergies;
- •No participation in other clinical trials within 2 months;
- •Have been informed consent.
- •Surgery-related: right subcostal incision, surgical time< 4 hours, hepatic pedicle occlusion time< 20 minutes, bleeding< 1000ml, no blood transfusions.
排除标准
- •History of chronic pain，long-term use of analgesic drugs or alcohol abuse;
- •Allergic to NSAIDs, opioids or sulfa drugs;
- •Coagulopathy or other hematological disorder；
- •Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease;
- •Pregnant or lactating;
- •Mentally unstable to use PCA;
- •Preoperative pain caused by other disease;
- •Analgesic drugs or NSAIDs intake one week before surgery;
- •Preoperative systemic inflammatory response syndrome;
- •Preoperative chemotherapy or radiotherapy;
- •Preoperative or postoperative use of steroids;
- •Operative time> 4 hours, hepatic pedicle occlusion time> 20 minutes, blood loss> 1000ml, or intraoperative blood transfusion;
- •TBil> 34 umol/L、PT prolongation> 3S、ALB< 30 g/L、or Child score> 7 within 42 hours after surgery；
- •Bleeding、biliary fistula, intra-abdominal infections or other postoperative complications.
研究组 & 干预措施
AT
Experimental
Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery
干预措施: Parecoxib Sodium (Drug)
结局指标
主要结局
VAS scores change
时间窗: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery
次要结局
- liver function change(befor and 42hrs and 66hrs after surgery)
- kidney function change(befor and 42hrs and 66hrs after surgery)
- blood ammonia level change(before and 42hrs, 66hrs after surgery)
研究者
研究点 (1)
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