Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery. A Double Blind Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Pain at rest
研究概览
简要总结
Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain.
There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks.
Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons
- •Locoregional anesthesia
- •Age equal to or greater than 18 years
- •Consent to participate in the study
排除标准
- •Age under 18 years old
- •General anesthesia
- •Allergy to local anesthetics
- •Severe kidney failure (Cr ≥ 2mg / dL)
- •Chronic opioid use (over 3 months)
- •Chronic pregabalin / gabapentin use (more than 3 months)
- •Psychiatric illness that may interfere with the evaluation or follow-up
研究组 & 干预措施
Echo-guided IPACK block
IPACK block using 0.25% bupivacaine 15mL with adrenaline once.
干预措施: IPACK block with Bupivacaine 0.25% with adrenaline (Drug)
Echo-guided sciatic block
Sciatic nerve block using 0.25% bupivacaine 15mL with adrenaline once.
干预措施: IPACK block with Bupivacaine 0.25% with adrenaline (Drug)
结局指标
主要结局
Pain at rest
时间窗: 48 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain at movement
时间窗: 6 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain with movement
时间窗: 48 hours after surgery
Measured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Motor block
时间窗: 48 hours after surgery
Measured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
次要结局
- Discharge days(Days)
- Ambulation time(Up to 24 hours)
- Opioids dose(48 hours after surgery)
- Patient satisfaction(24 hours after surgery)
研究者
Dinu
Principal Investigator
Germans Trias i Pujol Hospital