Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Pain scores assessed and recorded by using the numeric rating scale
研究概览
简要总结
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement with spinal anesthesia.
Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid consumption, a lower percentage of patients rescuing, or a longer time to first rescue with IV acetaminophen. The investigators will compare the efficacies of oral and intravenous acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
详细描述
Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies have shown several advantages of using intravenous acetaminophen perioperatively. However, due to its relatively high cost and limited clinical data concerning its efficacy compared with other agents, physicians are hesitant to use intravenous acetaminophen in the perioperative period.
174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate analgesia (total measured in milligrams) will be collected.
The difference in pain scores will be assessed by a chi-square test. A multivariable regression model will be performed with the clinical and statistically significant variables to remove confounding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing total knee replacement
- •Successful spinal placement
- •≥18 years old
排除标准
- •Failed spinal anesthesia
- •Chronic opiate users
- •Liver disease patients
- •Allergy/hypersensitivity to acetaminophen
- •Patients with baseline dementia
- •Patients weighing less than 50kg, history of alcohol dependence, renal impairment, opiate allergy, and pregnancy.
结局指标
主要结局
Pain scores assessed and recorded by using the numeric rating scale
时间窗: Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.
次要结局
- Postoperative nausea and vomiting(Participants will be followed for six hours postoperatively.)
- Time to rescue analgesia(Participants will be followed for the duration of their hospital stay, an expected average of one week)
- Time to post-anesthesia care unit (PACU) discharge(Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.)
- Opioid Use(Participants will be followed for six hours postoperatively.)
研究者
Jingping Wang, MD, Ph.D.
Assistant Professor
Massachusetts General Hospital