Effect of Intraoperative and Post-operative Opioids on Persistent Opioid Use in the Surgical Patient
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
A comparison of post-operative opioid use in Laparoscopic Colectomy patients receiving Opioid or Opioid-free Anesthesia.
详细描述
The study population will be composed of 100 patients total, 50 opioid-free anesthesia laparoscopic colectomy patients and 50 opioid anesthesia laparoscopic colectomy patients at Tampa General Hospital. After consent is obtained patients will be electronically randomized using REDCap in a 1:1 ratio and assigned to a opioid anesthesia or opioid free anesthesia group. Patients will also consent to be asked survey questions preoperatively and be followed for 12 months postoperatively at specific intervals to evaluate pain, satisfaction, and opioid prescription use. This will be done through a data mining platform and service known as REDCap. REDCap is partnered with USF to allow for subject management, data collection and the distribution of surveys via mobile phone. All data collected by REDCap is stored on a HIPPA compliant server. Patients will receive automated push notifications to their mobile phones to fill out surveys regarding their pill usage, pain, and satisfaction for a year or until cessation of opioid use is confirmed. Confirmation of opioid cessation will be performed on a case by case basis by the principal investigator, Dr. Camporesi. In addition to the surveys performed, nausea and pain scores will be collected prospectively from observation in the PACU
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
- Single (Participant)
盲法说明
Single Blinded: Study participants will not know what form of anesthesia they are being given.
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
- •Patients admitted to TGH for laparoscopic colectomy under Dr. Sanchez's care
- •Adults aged 18 and older
排除标准
- •Patients who are pregnant
- •Patients that are not registered within Tampa General Hospital Electronic Medical Records System
- •Patients without smart phone capabilities
- •Patients younger than 18 years
- •Patients older than 80 years
- •Patients who cannot speak or read English
研究组 & 干预措施
Opioid-free Anesthesia
Patients will receive no intraoperative narcotics as part of their anesthesia regimen
干预措施: Opioid-free Anesthesia (Drug)
Opioid Anesthesia
Patients will receive intraoperative narcotics as part of their anesthesia regimen
干预措施: Opioid Anesthesia (Drug)
结局指标
主要结局
Brief Pain Inventory
时间窗: Once a week for up to 12 months
a standardized 9 question survey broken into pain severity and pain interference sections. The sections rank various items relating to their respective categorizations of pain on a scale from 0 to 10. The arithmetic mean of each section can then be utilized to determine Severity of pain and impact of pain on daily function during the past week.
Post-surgical opioid prescription use, # of pills used per week
时间窗: Once a week for up to 12 months
Weekly pill use for pain management upon discharge
次要结局
- Patient Satisfaction(12 months)
- PACU: Opioid Use in Morphine Equivalents(1 - 3 hours)
- PACU: Pain Scores(1 - 3 hours)
- PACU: Nausea Scores(1 - 3 hours)
- Length of Stay(1- 5 days)