Analgesic Effect of Dexamethasone as a Perineural Adjuvant for Continuous Femoral Nerve Block After Total Knee Arthroplasty: a Prospective Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Maximum Numeric rating scale pain score at movement
研究概览
简要总结
An alternative to improve the quality of postoperative analgesia is to use various perineural adjuvants applicable to peripheral nerve block along with local anesthetics to increase the analgesic effect. Dexamethasone is a strong and long-acting corticosteroid, which reduces postoperative nausea and vomiting and increases the duration of nerve blockade. Most of the existing clinical studies compared the analgesic effect with the placebo group after adding an adjuvant in a single shot nerve block, and there were very few cases of comparing the analgesic effect with the placebo group after adding the adjuvant in peripheral nerve block through continuous catheter infusion. Therefore, we designed this study to investigate whether the use of dexamethasone as a peripheral adjuvant for continuous femoral nerve block has a better pain and recovery profile.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
排除标准
- •Revision total hip arthroplasty
- •Allergy to drugs used in the study
- •Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- •Estimated glomerular filtration rate < 30 mL/min/1.73m2
- •Opioid dependence
- •Prolongation of PT and aPTT more than twice the upper limit of normal
- •Pre-existing neurological or anatomical disorders of the lower extremities
- •Serious psychiatric disorders
研究组 & 干预措施
sham group
sham block before surgery
干预措施: sham group (Procedure)
结局指标
主要结局
Maximum Numeric rating scale pain score at movement
时间窗: within postoperative day 2
Pain intensity at movement will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) postoperative 1 hour, postoperative 6 hours, postoperative day 1, postoperative day 2. Maximum Numeric rating scale pain score was determined based on highest score among repeated assessment of surgical site pain severity postoperatively.
次要结局
- Numeric rating scale pain score at rest(up to postoperative day 2)
- Postoperative opioid consumption(up to postoperative day 2)
- Numeric rating scale pain score at movement(up to postoperative day 2)
研究者
Myoung Hwa Kim
Associate professor
Gangnam Severance Hospital