The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The measure is a composite outcome measure consisting of multiple measures,pain scores, sedation, nausea, pruritus, and respiratory rate.
研究概览
简要总结
The investigators hypothesized that using new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) would significantly improve postoperative pain control compare to conventional intravenous infusion pump of patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16 mg/8 mL + normal saline). This prospective randomized controlled trial was designed to evaluate the benefit of new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) for postoperative analgesia after laparotomic liver resection.
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
- Double (Investigator, Outcomes Assessor)
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
- •Patients need laparotomic liver resection.
排除标准
- •Patients with contraindications to spinal anesthesia or intrathecal morphine, difficulty understanding passive cutaneous anaphylaxis, a history of drug dependence or chronic pain, body mass index greater than 35 kg/m2, or history of sleep apnea were excluded from this study.
研究组 & 干预措施
conventional intravenous infusion pump
The first group receives conventional intravenous infusion pump of patient-controlled analgesia.
干预措施: conventional intravenous infusion pump (Procedure)
conventional intravenous infusion pump
The first group receives conventional intravenous infusion pump of patient-controlled analgesia.
干预措施: fentanyl citrate+ ondansetron hydrochloride + normal saline (Drug)
parecoxib
The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.
干预措施: parecoxib (Drug)
parecoxib
The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.
干预措施: celecoxib (Drug)
new intravenous infusion pump
The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.
干预措施: parecoxib (Drug)
new intravenous infusion pump
The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.
干预措施: intravenous infusion pump of patient-controlled analgesia (Procedure)
new intravenous infusion pump
The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.
干预措施: celecoxib (Drug)
结局指标
主要结局
The measure is a composite outcome measure consisting of multiple measures,pain scores, sedation, nausea, pruritus, and respiratory rate.
时间窗: With or without changes in the three days after surgery
Pain scores are evaluated with a visual analog scale of 0 to 100 and are measured at rest and with movement such as cough or incentive spirometry at 6, 9, 12, 18, 24, 36, 48 and 72 hours. Sedation, nausea, and pruritus are also measured at 6, 9, 12, 18, 24, 36, 48 and 72 hours. All the measures count together to get a composite outcome.
次要结局
未报告次要终点