Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Pain scores using numerical rating scale (NRS, 0 to 10)
研究概览
简要总结
An alternate perioperative pain control protocol composed of intravenous ketorolac and oral acetaminophen for patients who underwent total knee replacement was designed with the aim to determine its efficacy when compared to pain control with intravenous morphine and oral oxycodone combined with acetaminophen. In addition, the study will evaluate the differences and similarities in the Hispanic population that could predict protocol efficacy.
详细描述
Acute pain after a surgical procedure may occur secondary to trauma from the procedure itself or from procedure-related complications. Appropriate peri-operative acute pain management is an important phase of patient's recovery since it's under-treatment can lead to adverse outcomes such as: thromboembolic and pulmonary complications, additional time spent in an intensive care unit or hospital, hospital readmission for further pain management, needless suffering, impairment of health-related quality of life, and development of chronic pain. Furthermore, it's over-treatment with opioid medications is associated with an increased risk of thromboembolic, infectious and gastrointestinal complications as well as increased length of hospital stay, cost of care and risk of opioid addiction.
Perioperative administration of intravenous (IV) non steroidal anti-inflammatory drugs (NSAID), such as ketorolac, has been shown to effectively decrease opioid requirements and pain levels while demonstrating tolerable side effects. Its use after total knee replacement has been associated with a 27% decrease in the use of morphine. When NSAID is combined with acetaminophen 1000mg every six hours, an additional benefit in terms of improved pain scores on post-operative day three was shown in patients who underwent total hip or knee arthroplasty. Therefore, the purpose of this study is to provide an effective alternative for pain management in Hispanic patients who underwent total knee replacement and evaluate the role of ketorolac and acetaminophen.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hispanic American patients undergoing primary total knee arthroplasty
- •Older than 21 years of age
- •Classified with an American Society of Anesthesiologist Classification (ASA) of I or II.
排除标准
- •Hypersensitivity to any components of analgesic drugs
- •Impaired renal, cardiac, or hepatic function
- •Baseline serum creatinine level higher than 1.2mg/dL
- •History of gastrointestinal bleeding
- •Neuromuscular deformities
- •Inability to consent
研究组 & 干预措施
Opioid Sparing Multimodal Regimen
After surgery, the experimental group will receive a combination of ketorolac 30 mg intravenous (IV) every six hours for patients younger than 65 years old or ketorolac 15mg IV every six hours for those older than 65 years old; and acetaminophen 1 gram by mouth (PO) every six hours up to 72 hours
干预措施: Opioid sparing protocol (Drug)
Opioid Based Multimodal Regimen
After surgery, the control group will receive a combination of morphine 0.1 mg/kg IV every six hours and oxycodone combined with acetaminophen (2.5 mg / 325 mg) two tabs PO every six hours up to 72 hours
干预措施: Opioid based protocol (Drug)
结局指标
主要结局
Pain scores using numerical rating scale (NRS, 0 to 10)
时间窗: Post-operative 48 hours after surgery
The amount of pain intensity reported will be measure throughout the numerical rating scale. Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents "no pain," whereas 10 represents the "most intense pain" (e.g., "the most intense pain imaginable," "the maximum pain intensity as it could be"); during the 48 hours postoperative period
次要结局
- Drug-related adverse events(From the time of surgery after being discharge (0 to 72 hours after surgery))
- Hospital Length of Stay(up to 30 days)