Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The occurrence of postoperative nausea
研究概览
简要总结
The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.
详细描述
Nausea and vomiting in the post-operative period is considered strongly undesirable by patients and has adverse effects on recovery from outpatient procedures, contributing significantly to delays in discharge from recovery. A know major contributor to the occurrence of post-operative nausea and vomiting is the use of opiate medications which are the cornerstone of post-operative pain management. The investigators hypothesize that the occurrence of this side-effect is different between patients prescribed oxycodone and those receiving hydromorphone for acute pain management after total hip replacement surgery. This investigation is a randomized, double-blind, head-to-head comparison to equipotent administration of oxycodone vs. hydromorphone to determine whether such a difference exists.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Physical Status Classification System 1-3
- •Age 18-85 years
- •Patients undergoing hip replacement surgery under spinal anesthesia
排除标准
- •patient refusal
- •contraindication or refusal of spinal anesthesia
- •inability to provide informed consent
- •history of dementia
- •intolerance or allergy to oxycodone or hydromorphone
- •chronic opioid use or chronic pain disorder
- •pregnancy
- •history of drug addiction
- •history of major psychiatric illness
研究组 & 干预措施
Oxycodone
Patients will be prescribed oxycodone 10mg (5mg if > age 65) every 2 hours as needed for post-operative pain management in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours.
干预措施: Oxycodone (Drug)
Hydromorphone
Patients will be prescribed hydromorphone 2mg (1mg if > age 65) every 2 hours as needed in addition to tylenol 1000mg every 6 hours and celecoxib 200mg every 12 hours.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
The occurrence of postoperative nausea
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
The incidence and severity of nausea will be recorded twice daily up to 72 hours post-operatively
次要结局
- Daily pain scores(72 hours after surgery)
- Incidence of opioid related itching(72 hours after surgery)
- Incidence of delirium(72 hours after surgery)
- Cumulative in-hospital opioid consumption(72 hours after surgery)
- Use of anti-nausea medications(72 hours after surgery)
- Cumulative drug costs per patient(72 hours after surgery)
- Post-operative admission duration(Total admission duration, an expected average of 72 hours)