Are Adductor Canal Blocks With Bupivacaine and Added Magnesium Better at Managing Post-operative Pain Than Adductor Canal Blocks With Bupivacaine and Added Buprenorphine in Patients Undergoing Same-day Discharge Total Knee Arthroplasty?
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) pain score at 24 hours after surgery
研究概览
简要总结
The purpose of this study is to compare the use of magnesium and bupivacaine to buprenorphine and bupivacaine in post-operative adductor canal blocks (ACB); the study will determine if one combination can result in decreased opioid consumption and improved pain management for patients after same-day discharge total knee arthroplasty (TKA) .
The investigators will assess whether the addition of magnesium to bupivacaine 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 buprenorphine is added to bupivacaine.
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 and Bupivacaine
Patients in this arm (selected randomly) will receive an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine and 150mg of Mg.
干预措施: Adding Magnesium as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty (Drug)
Buprenorphine and Bupivacaine
Patients in this arm (selected randomly) will receive an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine and 300 mcg of buprenorphine.
干预措施: Adding Buprenorphine as an adjuvant to Bupivacaine in the adductor canal block (ACB) for same-day discharge total knee arthroplasty (Drug)
结局指标
主要结局
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)
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)
次要结局
- Percentage of incidence of post-operative nausea/ vomiting in first 48 hours after surgery(First 48 hours after surgery)
- Overall patient satisfaction in first 48 hours after surgery(First 48 hours after surgery)
研究者
Sandeep Krishnan
Associate Professor of Anesthesiology
Wayne State University