IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NRS scores
研究概览
简要总结
100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status according to American Society of Anesthesiologists (ASA) I-III
- •Patients scheduled for total knee arthroplasty
排除标准
- •Previous operation on same knee
- •Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
- •BMI above 32
- •Serious psychiatric, mental and cognitive disorders
- •Language barrier
- •Block failure
- •Chronic opioid, gabapentinoid use
- •Severe kidney disfunction
研究组 & 干预措施
Group A
干预措施: Adductor Canal Block plus IPACK Block (Drug)
Group B
干预措施: Adductor Canal Block (Drug)
结局指标
主要结局
NRS scores
时间窗: 48 hours
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Morphine consumption
时间窗: 24 hours
Morphine consumption in mg
Chronic pain
时间窗: 6 months
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting
次要结局
- Complications(48 hours)
- Patient satisfaction(48 hours)
- Intestinal function(5 days)
- Patient mobilization(5 days)
- Range of knee motion(48 hours)
- Delirium occurence(48 hours)
- Joint function(6 months)
研究者
Alexandros Makris
Consultant Anesthesiologist
Asklepieion Voulas General Hospital