Adductor Canal Blocks With Bupivacaine and Magnesium After Same-day Discharge Total Knee Arthroplasty Improve Post-operative Pain Relief and Decrease Opioid Consumption: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Total opioid consumption (oral morphine equivalents) in the first 24 hours after surgery
研究概览
简要总结
The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks (ACB) can decrease opioid consumption and improve pain management for patients after same-day discharge total knee arthroplasty (TKA).
The investigators will assess whether the addition of magnesium will decrease visual analog scale (VAS) pain scores, decrease post-operative total opioid consumption (oral morphine equivalents), decrease the incidence of post-operative nausea and vomiting (PONV), and improve patient satisfaction in comparison to when magnesium is not administered.
详细描述
Total knee arthroplasty (TKA) is one of the most common elective surgical procedures in the United States . The number of TKA procedures has doubled in each of the past two decades and is expected to top 3.4 million per year in the United States by 2030.
Within the last 10-15 years significant changes have taken place in the anesthetic management of patients undergoing total knee arthroplasty (TKA). In the past, the majority of patients underwent general anesthesia and were managed post-operatively with a PCA (patient controlled analgesia) pump.
More recently anesthesiologists have begun to use neuraxial anesthesia (spinal anesthesia) combined with regional anesthesia (peripheral nerve block (PNB)) techniques combined with monitored anesthesia care (MAC) for many of these surgeries.
Regional anesthesia is used to block the sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques.
However, the duration of traditional amide-based and ester-based regional anesthesia is normally limited to only a few hours. Techniques including continuous catheter placement or serial injections can be used to enhance the duration and effect of regional anesthesia for postoperative pain control. But these approaches can increase the risk of infection, toxicity, and cost. Therefore, alternative methods of extending the clinical duration of nerve blocks have been a topic of significant interest.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral primary total knee arthroplasty with spinal anesthetic and MAC followed by a unilateral adductor canal block with ultrasound guidance.
排除标准
- •Patients on chronic anticoagulation upon admission
- •Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.) or significant platelet dysfunction
- •Patients with prior back surgery or leg surgery that precludes spinal or regional anesthesia
- •Infection at sites for regional/spinal anesthesia
- •Allergy to local anesthetics
研究组 & 干预措施
Mg
Treatment Group. Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Patients in this Arm (selected randomly) will receive 150 mg Mg (0.3 mL-the intervention) in the block.
干预措施: Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplasty (Drug)
结局指标
主要结局
Total opioid consumption (oral morphine equivalents) in the first 24 hours after surgery
时间窗: The first 24 hours after surgery
Measuring the post surgical total opioid consumption in the first 24 hours after surgery by calculating oral morphine equivalents (mg)
Total opioid consumption (oral morphine equivalents) in the second 24 hours after surgery
时间窗: The second 24 hours after surgery
Measuring the post surgical total opioid consumption in the second 24 hours after surgery by calculating oral morphine equivalents (mg)
Visual analog scale (VAS) pain score at 24 hours after surgery
时间窗: 24 hours after surgery
Determining pain scores using Visual analog scale (VAS) at 24 hours after surgery (0-10, Higher scores mean worse outcome)
Visual analog scale (VAS) pain score at 48 hours after surgery
时间窗: 48 hours after surgery
Determining pain scores using Visual analog scale (VAS) at 48 hours after surgery (0-10, Higher scores mean worse outcome)
次要结局
- Overall patient satisfaction in first 48 hours after surgery(First 48 hours after surgery)
- Percentage of incidence of post-operative nausea/ vomiting in first 48 hours after surgery(First 48 hours after surgery)
研究者
Sandeep Krishnan
Clinical Associate Professor of Anesthesiology
Wayne State University