A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain Levels
研究概览
简要总结
To help curb the use of opioid medications following orthopedic surgery investigators have developed a new multi-modal pain pathway. Investigators aim to compare this regimen with and without the inclusion of opioid medications. This study will be performed in a randomized, double-blinded, placebo-controlled fashion in patients undergoing primary total knee or total hip arthroplasty. Investigators hypothesize that the opioid devoid pathway will show equivalent pain scores to the pathway that includes opioids while also having less constipation, nausea, and vomiting following surgery. If successful, this would create a dramatic decrease in opioid consumption following orthopedic surgery while still providing appropriate pain relief to patients.
详细描述
- Aim 1 will be to compare the postoperative pain levels both in the hospital setting as well as daily for two weeks following discharge between patients in the opioid treatment group and those in the non-opioid treatment group. This will be performed with clinical exams while in the hospital and with phone surveys on discharge. Results will be recorded using the Visual Analog Scale for pain scores.
- Aim 2 will be to compare the overall morphine equivalents used during hospitalization between the opioid and non-opioid treatment groups. This will be calculated based on the amount of intravenous breakthrough narcotic pain medication used in the hospital setting (divided by the total number of post-surgery hospitalization hours to account for varying lengths of stay). Investigators will also measure the total number of opioid pills (these would be placebo pills for the non-opioid group) consumed during the first two weeks post-discharge, and the post-surgery day on which opioid pills were discontinued, and compare these outcomes between the opioid and non-opioid groups.
- Aim 3 will be to compare postoperative constipation, nausea, and vomiting between the two treatment groups. This will be assessed with daily clinical examinations while in the hospital and with daily phone surveys on discharge. Constipation will be recorded as presence or absence, while nausea and vomiting will be measured using the Postoperative Nausea and Vomiting Scale.
- Aim 4 will be to compare the length of post-surgery hospitalization between the two treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The oxycodone and placebo tablets will be encapsulated by the research pharmacy prior to dispensing for blinding purposes.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 90 years.
- •Willing to participate in the study and competent to provide informed consent.
- •Willing to comply with protocol procedures.
- •Has an underlying diagnosis of osteoarthritis indicated for knee arthroplasty.
排除标准
- •A diagnosis of renal or liver disease
- •If a patient has a contraindication to receiving a spinal anesthetic or pain catheter
- •The patient must not have taken any narcotic medications during the 3 months leading up to the surgery
- •The patient must not be allergic or intolerant to a medication used in the multi-modal pain pathway
- •Revision hip or knee arthroplasty
- •If a patient is being treated under worker's compensation
- •If a patient has diabetes
- •Unable to take Aspirin 325 mg twice daily for deep venous thromboprophylaxis
研究组 & 干预措施
Opioid
Multi-Modal Pain Protocol with Opioids Following Total Joint Arthroplasty
干预措施: Oxycodone (Drug)
Non Opioid
Multi-Modal Pain Protocol without Opioids Following Total Joint Arthroplasty
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Pain Levels
时间窗: 2 weeks
compare the postoperative pain levels both in the hospital setting as well as daily for two weeks following discharge between patients in the opioid treatment group and those in the non-opioid treatment group. This will be performed with clinical exams while in the hospital and with phone surveys on discharge. Results will be recorded using the Visual Analog Scale for pain scores. This scale ranges from 0 to 10, with zero being no pain and 10 being as bad as can be, and includes visual facial cues. Following this scale, investigators will also ask about sleep, activity, mood, and stress.
次要结局
- Opioid Levels(2 weeks)
- Length of hospitalization(2 weeks)
- Side effects(2 weeks)
研究者
Benjamin K. Wilke
Principal Investigator
Mayo Clinic