Low Versus Standard Concentrations and Volumes Local Anesthetics Boluses for Continuous Adductor Canal Block Under Ultrasound-guidance in Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Average knee pain score assessed by Numerical rating scale (NRS)
研究概览
简要总结
To investigate the efficacy of two different regimens of local anesthetic boluses for continuous adductor canal block under ultrasound-guidance in total knee arthroplasty at King Chulalongkorn Memorial Hospital.
详细描述
Total knee arthroplasty (TKA) is a commonly performed surgical procedure for patients with severe knee osteoarthritis. However, one of the challenges associated with TKA is the significant postoperative pain experienced by patients, which can delay early mobilization and physical therapy. Uncontrolled pain worsens patient outcomes and healthcare costs as it can increase the risk of complications after surgery. Therefore, effective pain management is important for optimizing patient outcomes and promoting a smooth recovery process.Despite the absence of a standardized recommendation for the volume and concentration of bolus administration in continuous adductor canal block (CACB), many previous studies, have demonstrated the efficacy of a high-dose bolus followed by a low-concentration local anesthetic infusion for CACB. However, these trials exhibited differences in the doses and volumes of bolus injection. Therefore, the necessity of high concentration and volume bolus CACB in combination with comprehensive multimodal analgesia and LIA for postoperative pain management in TKA remains uncertain. The aim of this study is to investigate the efficacy of two different regimens of local anesthetic used in boluses for continuous adductor canal block under ultrasound-guidance in total knee arthroplasty at King Chulalongkorn Memorial Hospital.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing TKA aged more than 18 years
- •Patients with American Society of Anesthesiologists (ASA) class 1-3
- •Patients with body weight index (BMI) 18-40 kg/m2
- •Exclusion Criteria
- •Patient refusal to participate
- •Patients with known allergic to medications used in the research protocol
- •Patients with contraindications to neuraxial or regional anesthesia, including existing neuropathy or neurological deficits involving the lower extremities, coagulopathy or bleeding diathesis and local skin infections
- •Patients with contraindications to NSAIDs such as history of coronary artery bypass graft surgery, congestive heart failure, stroke, gastrointestinal bleedings or ulceration, asthma, hepatic and renal disease, abnormal coagulation, or pregnancy
- •Patients with chronic opioid use (opioids have been used daily or almost daily for more than three months or sixty milligrams or more of morphine has been used daily for more than one month) or diagnosed with neuropathic pain
- •Patients that are unable to perform preoperative Quantitative sensory testing.
排除标准
- 未提供
研究组 & 干预措施
Low Concentration and Volume
0.15% bupivacaine 10 ml boluses for continuous adductor canal block
干预措施: Low bolus concentration and volume (Drug)
Standard Concentration and Volume
0.25% bupivacaine 20 ml boluses for continuous adductor canal block
干预措施: Low bolus concentration and volume (Drug)
结局指标
主要结局
Average knee pain score assessed by Numerical rating scale (NRS)
时间窗: 12 hours after surgery
Average postoperative pain score assessed by NRS from 0-10 (0= no pain, 10= the worst pain imaginable)
次要结局
- Functional outcomes assessed by Five Times Sit to Stand Test (5XSST)(preoperative - postoperative day 2)
- Functional outcomes assessed by Time Up and Go (TUG) test(preoperative - postoperative day 2)
- The degree of active range of motion (ROM) of knee joint(preoperative - postoperative day 2)
- Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newton(preoperative - postoperative day 2)
- morphine consumption in milligrams(post0perative day 0-2)
- Postoperative pain score assessed by Numerical rating scale (NRS)(preoperative to day 7 after hospital discharge)
- postoperative complications assessed by Likert scale(postoperative day 0-2)
- The time to first rescue analgesia(postoperative day 0-2)
研究者
Wirinaree Kampitak, MD
Clinical Associate Professor
Chulalongkorn University