Open-Label Randomized Controlled Trial to Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Perioperative Anxiety
研究概览
简要总结
Open-label, randomized controlled trial to determine the effect of preoperative acupuncture on preoperative anxiety and postoperative pain for high-anxiety patients undergoing total hip or knee arthroplasty. The hypothesis is that preoperative acupuncture will reduce preoperative anxiety, reduce postoperative pain, reduce postoperative nausea and vomiting, reduce opioid consumption, and improve patient satisfaction.
详细描述
Acupuncture has been extensively practiced and studied worldwide, particularly as a part of Eastern medicine, but it is a relatively uncommon therapy offered in Western medical institutions, such as those in the United States. Considering the commonly cited benefits of acupuncture, such as reduced anxiety and pain, hospitals throughout the United States have the opportunity to implement acupuncture as a cost-effective and safe technique for improving surgical outcomes.
Acupuncture administered in the preoperative period can be particularly effective for reducing preoperative anxiety, postoperative pain, postoperative opioid consumption, and postoperative nausea and vomiting. Consequently, preoperative acupuncture can improve patient satisfaction and decrease hospital costs. However, due to a lack of implementation and experience, further research is needed to establish the safety and efficacy of preoperative acupuncture in United States medical practices.
At the Bone-and-Joint Institute at Hartford Hospital, where this study is proposed, a quality study on total knee or hip arthroplasty patients found that 21% of its monthly patients were "high-anxiety" according to the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Thus, there is a significant population of patients who would benefit from a procedure to reduce preoperative anxiety at our facility.
This proposal is for a prospective, open-label, randomized controlled trial to determine the effect of preoperative acupuncture on preoperative anxiety and postoperative pain for high-anxiety patients undergoing total hip or knee arthroplasty. The hypothesis is that preoperative acupuncture will reduce preoperative anxiety and postoperative pain as well as reduce postoperative nausea and vomiting and opioid consumption and improve patient satisfaction. The study population is to include adult patients undergoing lower extremity total joint arthroplasty, including hip and knee joints, at the Bone-and-Joint Institute at Hartford Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female (age 52 to 85) or male (age 18-85) patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty at the Bone-and Joint Institute at Hartford Hospital
- •Patients classified as high-anxiety based on having a score of >10 on the Amsterdam Preoperative Anxiety and Information Scale (APAIS-A-T). The APAIS-A-T is a modified survey that reliably quantifies total preoperative anxiety using summed scores for anesthesia and surgery-related anxiety; a minimum score of 11 is the most accurate cutoff to identify patients with anxiety
排除标准
- •Unable to give consent
- •Uncontrolled diabetes (HbA1c ≥ 8.0%)
- •Infection at any of the acupuncture points
- •Known allergy to metals
- •Abnormal laboratory blood work values (INR>1.5, if available; platelet count <70,000, if available)
- •Patients with active ongoing coagulopathy based on lab data (INR >1.5) and/or on current anticoagulant use which increases bleeding risk.
- •Non-English speaking
- •Revision TKA or THA
- •Women of reproductive age or under the age of 52 years old, as acupuncture is not recommended during pregnancy. They were excluded due to the potential conflict between our institute's standard timing for pregnancy tests on the day of surgery and the scheduled preoperative acupuncture session for the study, to avoid unwanted delays in the operating room schedule.
结局指标
主要结局
Perioperative Anxiety
时间窗: Prior to acupuncture and 30 minutes after acupuncture
Determine the effect of preoperative acupuncture on preoperative anxiety in the acupuncture group using VAS (Visual Analog Scale) which is a 10 centimeters line in length, from 0-100, with 0 at the left extreme being "not at all anxious" and 100 at the right extreme being "very anxious". Participants put a cross on the line to indicate how they felt at the time point used. A higher score means worse as it means high anxiety.
Postoperative Pain in the First 3 Postoperative Hours
时间窗: Total mean pain in the first 3 postoperative hours
Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is "no pain" and 10 is "severe pain". Using the mean pain score to compare the mean of the total pain in the first 3 postoperative hours between groups.
次要结局
- Patient Satisfaction With Acupuncture Procedure(Within 1 week after hospital discharge)
- Preoperative Pain(Prior to acupuncture and 30 minutes after acupuncture)
- Opioid Consumption(During hospitalization, up to 24 hours post surgery)
- Midazolam Use as Anxiolytic Medications(During hospitalization, up to 24 hours post surgery)
- Patient Satisfaction Scale With Overall Care(Within 1 week after hospital discharge)
- Occurrence of Nausea and Vomiting at First Postoperative Hour(At 1 postoperative hour)
- Antiemetic Medications(During hospitalization, up to 24 hours post surgery)
- Hospital Length of Stay(From the date and time of admission to the date and time of discharge, assessed as 24-48 hours)
- Postoperative Pain Upon Arrival to the PACU(Postoperative pain at time of PACU arrival)
- Postoperative Pain at 1 Postoperative Hour(At the first postoperative hour)
- Postoperative Pain After 3 Postoperative Hours(After three postoperative hours)
- Number of Participants That Received Midazolam Dose >2mg(During hospitalization up to 24 postoperative hours)
- Patient's Satisfaction With Pain Management(Within 1 week after hospital discharge)
- Patient's Satisfaction With Anxiety Management(Within 1 week after hospital discharge)
- Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries(Within 1 week after hospital discharge)
- Occurrence of Nausea and Vomiting After 3 Postoperative Hours(After 3 postoperative hours)
- Postoperative Pain in the First 3 Postoperative Hours (Group X Time)(Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour)
研究者
Pranjali P Kainkaryam, MD
Principal Investigator
Hartford Hospital