Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 484
- 试验地点
- 1
- 主要终点
- Opioid Usage
研究概览
简要总结
At this time, no formal ERAS (enhanced recovery after surgery) protocol exists for THR that incorporates perioperative acupuncture. Developing, and more importantly, validating a preliminary fast-track protocol for THR can have a significant impact on reducing recovery time and improving the rate at which this subgroup of surgeries is done on an outpatient basis. Furthermore, previous studies of acupuncture as an adjunctive therapy for postoperative analgesia have primarily investigated patient satisfaction rather than the impact on postoperative opioid consumption.
The majority of studies also place acupuncture needles preoperatively, rather than following induction of anesthesia (intra-operatively). This study hopes to show that placing auricular therapy needles intraoperatively is a feasible part of a protocol for motivated patients to minimize opioids after total knee arthroplasty. The prospect of incorporating intraoperative acupuncture as an adjunct into said protocol is very attractive given its low cost, its safety profile, its ease of administration, and the growing evidence supporting its efficacy. This study would provide further clarity on whether perioperative acupuncture can effectively reduce hospital length of stay and post-operative opioid consumption, in addition to evaluating the role of perioperative acupuncture in improving recovery after THR as part of a multimodal fast-track protocol.
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 (Participant, Outcomes Assessor)
盲法说明
Both patients and research assistants (RAs)collecting data from the patients will be blinded.
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
- 否
入选标准
- •ASA status of 1 or 2
- •Ages 18-80
- •Undergoing a total hip replacement
- •Ability to follow study protocol
- •English-speaking
排除标准
- •Non-English speaking
- •Chronic opioids use (6 weeks or more)
- •Contraindication to neuraxial anesthesia or peripheral nerve block
- •Intending to receive general anesthesia
- •Contraindication to intra-op protocol
- •Implanted cardiac device (i.e. pacemaker)
- •Active ear infection
- •Non-native ear, previous scarring or surgery
- •Ear gauges or other deforming ear piercing
- •Allergy to Nickel
研究组 & 干预措施
Active Acupuncture Group
For the patients randomized to the acupuncture group, once sedation has been deemed adequate by the anesthesiologist, a certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed.
干预措施: Auricular Trauma Protocol (ATP) Acupuncture (Device)
Placebo No Acupuncture Group
These patients will not receive acupuncture treatment during surgery, their surgery will continue as normal.
干预措施: No Acupuncture Group (Other)
结局指标
主要结局
Opioid Usage
时间窗: Day 30
The primary outcome is the incidence of patients who maintain a low-dose opioid regimen (71.5 OME or less) out to 30 days post-op. Patient intake of opioid medication will be measured up to the 30 days post-operation.
次要结局
- Hours to Discharge(Will be assessed up to 4 days post-operatively or until patient leaves hospital.)
- NRS Pain Scores(Post-operatively in: PACU (post-anesthesia care unit) immediately post-operation, Day 1, Day 2, Day 14 & Day 30)
- Post-operative Nausea & Vomiting (PONV)(Post-operatively in: PACU (post-anesthesia care unit), Day 1)
- Range of Motion(Post-operatively on: Day 1 and Day 14)
- Pain Catastrophizing Scale (PCS)(Pre-operative)
- Center for Epidemiologic Studies Short Depression Scale & Anxiety Scale (CES-D)(Pre-operative)
- Satisfaction with Protocol(Day 30)