Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total amount of opioid consumption postoperatively
研究概览
简要总结
The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia) on an as needed basis within a well defined fast track protocol that includes multimodal analgesia for patients who are undergoing elective primary knee replacement surgery. The investigators assumed that with the multimodal analgesia regimen without the use of IVPCA will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids related side effects and decreased length of stay in the hospital.
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 (Outcomes Assessor)
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
- 是
入选标准
- •Male or female patients aged 18 to 80 years old
- •Provision of written informed consent
- •Patients scheduled to undergo primary knee surgery included in the fast track protocol under regional anesthesia only
- •Patients with Body Mass Index (BMI) between 18 to 34.9
- •Patients with American Society of Anesthesiologists (ASA) physical status classification of 1 to 3
排除标准
- •Patients on chronic (more than twice a week) opioid treatment including Tylenol #3, percocet, morphine, methadone, hydromorphone, fentanyl patch and other potent opioids
- •Patients with language barrier or difficulty in communication in English
- •Patients who are allergic to morphine and hydromorphone, fentanyl, gabapentin, celecoxib or acetaminophen
- •Patients with increased risk for respiratory depression with intrathecal morphine (OSA, central apnea)
- •Patients with documented Renal or hepatic impairment
研究组 & 干预措施
Analgesia, patient controlled
Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
干预措施: Morphine as IVPCA (Drug)
Analgesia, patient controlled
Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of either morphine or hydromorphone.
干预措施: Hydromorphone as IVPCA (Drug)
Analgesia, as per needed
Patients will receive intravenous (IV) opioids as per needed.
干预措施: Morphine (Drug)
Analgesia, as per needed
Patients will receive intravenous (IV) opioids as per needed.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Total amount of opioid consumption postoperatively
时间窗: Every 24 hours for up to 48 hours after randomization
次要结局
- Opioid related side effects.(Every 24 hours for up to 48 hours after randomization)
- Patient satisfaction(Once at 48 hours after randomization)
- Pain scores measured at rest and movement(Every 12 hours for up to 48 hours after randomization)
- Length of stay in hospital(One week)
研究者
Naveed Siddiqui
Assistant professor
Mount Sinai Hospital, Canada