A Multicentre, Double-Blind, Placebo-Controlled Study of the Recovery Benefits Following Treatment With a Cox-2 Regimen in Patients Undergoing Elective Laparoscopic Intra-Peritoneal Abdominal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
研究概览
简要总结
The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.
详细描述
This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery
- •American Society of Anaesthesiologists (ASA) Physical Status I-III
排除标准
- •Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results
- •Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect
研究组 & 干预措施
Group 1
干预措施: Parecoxib/Valdecoxib (Drug)
Group 2
干预措施: Placebo (Drug)
结局指标
主要结局
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
时间窗: 4 hours
次要结局
- Evaluation of unplanned hospital admissions on Day 4.(4 days)
- Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.(4 days)
- Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.(4 days)
- Length of stay on Day 1.(1 day)
- Patient Satisfaction Questionnaire on Days 1 and 4.(4 days)
- Quality of Recovery Score on Days 1, 2, and 3.(3 days)
- Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.(4 days)
- Modified Brief Pain Inventory on Days 2, 3, and 4.(4 days)
- Readiness for discharge on Day 1.(1 day)