Analgesic Efficacy of Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Average NRS pain score at rest
研究概览
简要总结
This study will compare the analgesic efficacy of daily single-shot adductor canal block(ABC) versus continuous ACB after total knee arthroplasty (TKA).
详细描述
Patients 19-75 years old, of ASA classification I-III scheduled for unilateral TKA, will be enrolled and randomized into two groups, single-shot ACB group and continuous ACB group. In both groups, participants will be administered a single-shot ACB immediately after the end of the operation. The single-shot ACB group will receive two separate single-shot ACBs, on the first and second postoperative day. A nerve block catheter will be placed in patients in the continuous ACB group, which will be connected to a patient-controlled analgesia pump until the second postoperative day. The primary outcome of this study is the average NRS pain score at rest from the end of surgery to 2 days after surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA classification I, II, III
- •Patients scheduled for unilateral knee arthroplasty
排除标准
- •Anesthesia other than spinal anesthesia
- •Chronic opioid use
- •Uncontrolled diabetes of HbA1c>7.5
- •Neuromuscular pathology of the ipsilateral leg
- •Second-look knee arthroplasty
- •Inability to communicate (e.g. dementia)
- •Hypersensitivity to ropivacaine
- •BMI > 40
- •Pregnancy
研究组 & 干预措施
Single shot adductor canal block
干预措施: Single shot adductor canal block (Procedure)
Continuous adductor canal block
干预措施: Continuous adductor canal block (Procedure)
结局指标
主要结局
Average NRS pain score at rest
时间窗: first 48h after end of surgery
average of numerical rating scale (0: no pain, 10: worst imaginable pain) pain scores from 8 time points during 48h (+4h, +8h, +12h from end of surgery, 6AM, 2PM, 10PM of postoperative day 1, and 6AM and 2PM of postoperative day 2)
次要结局
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 1(6AM on postoperative day 1)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 6AM on postoperative day 1(6AM on postoperative day 1)
- NRS pain score at rest at 2PM on postoperative day 1(2PM on postoperative day 1)
- NRS pain score at rest at 10PM on postoperative day 1(10PM on postoperative day 1)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 10PM on postoperative day 1(10PM on postoperative day 1)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 2PM on postoperative day 2(2PM on postoperative day 2)
- Postoperative range of motion of knee joint(at 2PM on postoperative day 1 and 2)
- NRS pain score during movement at 2PM on postoperative day 1(2PM on postoperative day 1)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 2(6AM on postoperative day 2)
- NRS pain score during movement at 6AM on postoperative day 2(6AM on postoperative day 2)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 2PM on postoperative day 2(2PM on postoperative day 2)
- Posteoperative opioid administration in morphine equivalents(from end of surgery to 48h after surgery)
- Incidence of catheter tip dislocation(at 2PM on postoperative day 1 and 2)
- Incidence of extravasation from catheter insertion site(at 2PM on postoperative day 1 and 2)
- Incidence of sleep disturbance due to pain(from end of surgery to postoperative day 2)
- Incidence of numbness of anterior thigh area(at 2PM on postoperative day 1 and 2)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +4h from end of surgery(+4h from end of surgery)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +4h from end of surgery(+4h from end of surgery)
- NRS pain score at rest at +8h from end of surgery(+8h from end of surgery)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +8h from end of surgery(+8h from end of surgery)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +12h from end of surgery(+12h from end of surgery)
- numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +12h from end of surgery(+12h from end of surgery)
- Strengh of quadratus femoris muscle (unit: kgf)(at 2PM on postoperative day 1 and 2)
- Incidence of falls during hospital stay(from end of surgery to 48h after surgery)
研究者
Seokha Yoo
Clinical assistant professor
Seoul National University Hospital