Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Low-dose Opioid Regimen Adherence
研究概览
简要总结
The majority of patients undergoing total knee replacement(TKR) rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. The aim of this cohort study is to determine the incidence rate of patients who are able to maintain a low dose opioid regimen after TKR with the use of a multimodal approach that includes intraoperative auricular acupuncture protocol.
详细描述
This is a prospective cohort study to assess the feasibility of patients to undergo TKR while adhering to a low-dose opioid regimen by using a multimodal analgesic approach that includes intraoperativeauricular acupuncture. We hypothesize that it will be feasible to maintain a low-dose opioid regimen during TKR while followingthe intraoperative auricular acupuncture protocol, and that patients will be satisfied with their pain control with a low incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA of 1 or 2
- •Age 18-70
- •Undergoing primary total knee replacement
- •Desire to attempt a low opioid or opioid free pathway
排除标准
- •NonEnglish speaking
- •Patients with the inability to understand or follow study protocol
- •Opioid use in the last 6 weeks or chronic pain patient
- •Cannot receive neuraxial anesthesia and/or peripheral nerve block
- •Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease)
- •Patients with implanted cardiac device such as a pacemaker or AICD
- •Active ear infection
- •Nonnative ear, previous scarring or surgical manipulation of ear
- •Patients with gauges or other deforming ear piercing (small nondeforming ear piercings are ok) present in ears
- •Allergy to nickel
结局指标
主要结局
Low-dose Opioid Regimen Adherence
时间窗: postoperative day 0 to postoperative day 30
The number of patients who maintain a low-dose opioid regimen (15 pills or less of 5mg oxycodone or 112.5 OME \[oral morphine equivalents\]) from postoperative day (POD) 0 to POD 30 throughout their Total Knee Replacement.
次要结局
- Total Opioid Consumption(post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30)
- Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement(post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30)
- Duration of Neuraxial Anesthesia in Hours(postoperative day 1)
- Deviation From Prescribed Oral Pain Regimen(Postoperative day 30)
- Number of Participants With Side Effects on POD1 and During the PACU Stay(PACU, Postoperative day 1)
- Postoperative Range of Motion(6 weeks postoperative (surgeon office visit))
- Tourniquet Time(Intraoperatively)