A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge.
研究概览
简要总结
This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.
详细描述
Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Hypothesis
Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.
Hypothesis
Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Undergoing ambulatory surgery under general anesthesia
- •Expected postoperative pain to be mild-moderate
- •Age 18 years or older
- •Have an ASA physical status or 1, 2, or 3
排除标准
- •Anticipated peripheral or neuraxial nerve block
- •Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
- •Current chronic opioid or tramadol use
- •History of alcohol or opioid abuse
- •Known allergy to the study medications
- •Pregnancy
- •Any health condition requiring greater than 100 micrograms of fentanyl during anesthesia induction
- •Treated with any acetaminophen-containing medication in the previous 8 hours
- •Treated with MAO inhibitors within 10 days prior to surgery
- •Inability to communicate with the investigators and hospital staff
- •Known or impaired liver function
研究组 & 干预措施
IV Acetaminophen
Intraoperative IV acetaminophen administered
干预措施: Intravenous acetaminophen (Drug)
IV Placebo
Intraoperative IV normal saline administered
干预措施: Intravenous placebo (Drug)
结局指标
主要结局
The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge.
时间窗: Day of Surgery
次要结局
- A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient.(Day of Surgery)
- A secondary outcome for this investigation will be the total dose of morphine administered to the patient.(Day of Surgery)
- A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient.(Day of Surgery)
- A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient.(Day of Surgery)
- A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration.(Day of Surgery)
- A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient.(Day of Surgery)
- Patients will be asked at time of PACU discharge, "Overall, how would you rate the study treatments?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.(Day of Surgery)
- Patients will be asked at time of PACU discharge, "Overall, how would you rate the level of pain relief from study medication?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.(Day of Surgery)
- Adverse events(Up to one year postoperative)
研究者
Brian M. Ilfeld, MD, MS
Associate Professor, In Residence
University of California, San Diego