A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain score on post-operative day one
研究概览
简要总结
Given the nationwide epidemic of opioid use and abuse (in part due to over prescription), this study aims at addressing the need for opioid prescription after laparoscopic hysterectomy.
详细描述
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether non-opioid multimodal medications are adequate in treating postoperative pain after laparoscopic hysterectomy and would not increase the need for additional prescriptions or unscheduled patient contacts. This study aims to find the optimal prescriptions for pain after laparoscopic hysterectomy in an attempt to eliminate opioid use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications
排除标准
- •Allergy or other contraindication to the prescribed medications such as acetaminophen, ibuprofen, or oxycodone
- •Known opioid use or abuse (defined as reported use or treatment for abuse within the last 3 months)
- •Chronic pain patients
- •Conversion to laparotomy
- •Malignancy as the indication for surgery
研究组 & 干预措施
No Opioid prescription
Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, will receive Meloxicam 15mg daily x 48 hours then as needed
Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)
干预措施: Acetaminophen 500 mg Tab (Drug)
Post-operative opioid prescription
Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed
Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)
Oxycodone 5mg every 4 hours as needed (total 12 tablets)
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
Post-operative opioid prescription
Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed
Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)
Oxycodone 5mg every 4 hours as needed (total 12 tablets)
干预措施: Acetaminophen 500 mg Tab (Drug)
Post-operative opioid prescription
Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed
Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)
Oxycodone 5mg every 4 hours as needed (total 12 tablets)
干预措施: Ibuprofen 600 mg (Drug)
No Opioid prescription
Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, will receive Meloxicam 15mg daily x 48 hours then as needed
Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)
干预措施: Ibuprofen 600 mg (Drug)
结局指标
主要结局
Pain score on post-operative day one
时间窗: 1 day
Numeric pain score on post-operative day one: patient reported pain using the Likert pain scale from 0 to 10
Pain score on post-operative day seven
时间窗: 7 days
Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10
次要结局
- Mobility on postoperative day seven(7 days)
- Total opioid consumption on postoperative day one(1 day)
- Satisfaction of pain control on postoperative day one(1 day)
- Total opioid consumption on postoperative day seven(7 days)
- Opioid related side effects on postoperative day one(1 day)
- Satisfaction of pain control on postoperative day seven(7 days)
- Mobility on postoperative day one(1 day)
- Opioid related side effects on postoperative day seven(7 days)
- Unplanned calls/visits(7 days)