IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Number of Participants With Postoperative Nausea and Vomiting (PONV).
研究概览
简要总结
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.
详细描述
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
- •American Society of Anesthesiology patient classification status I-II
排除标准
- •Regular preoperative use of or opioids,
- •Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
- •Subjects converted to open laparoscopic cholecystectomy
- •Known allergy/hypersensitivity to acetaminophen
- •Use of opioids prior to commencement of the study (<7 days)
- •Patients with chronic pain conditions or disease requiring pain control
- •Abnormal liver function
- •Known or suspected alcohol, drug or opiate abuse or dependence
- •Patients with a BMI of greater than 35
- •Other physical, mental or medical conditions that could effect participation.
- •Abnormal renal function; serum creatinine>2gm/dl
研究组 & 干预措施
IV Acetaminophen
IV Acetaminophen administered on admission to post-anesthesia care unit
干预措施: IV Acetaminophen (Drug)
Standard of care
Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit
干预措施: Standard of Care (Drug)
结局指标
主要结局
Number of Participants With Postoperative Nausea and Vomiting (PONV).
时间窗: 4 hours plus/minus 30 minutes
Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.
次要结局
- Number of Participants With Post Discharge Nausea and Vomiting (PDNV)(Up to two days following surgery)
- Highest Pain Intensity Score Using Numeric Rating Scale (NRS)(4 hours plus/minus 30 minutes)
- Patient Satisfaction on a 5 Point Likert Scale(Up to one week following surgery)
- Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale(1 hour following surgery)