Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Postoperative Narcotic Use
研究概览
简要总结
Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug.
The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary inguinal and/or umbilical hernia repair
- •age > 18 years old
排除标准
- •history of gastrointestinal bleeding
- •allergy to ibuprofen
- •creatinine > 1.5 mg/dL
研究组 & 干预措施
IV Caldolor
干预措施: Intravenous Ibuprofen (Drug)
Placebo
干预措施: IV Placebo (Other)
结局指标
主要结局
Postoperative Narcotic Use
时间窗: 7 days
Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.
次要结局
- Postoperative Visual Analog Pain Scale(7 days)
研究者
Ronald S. Chamberlain
Chairman and Chief Department of Surgery
St. Barnabas Medical Center
