The Effect of Distal Versus Proximal Approach to the Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee (iPACK) on Pain After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- total opioids consumption
研究概览
简要总结
Total knee arthroplasty (TKA) often results in significant postoperative pain, which can hinder recovery despite advances in surgical and anesthetic techniques. Traditional pain management methods like femoral nerve blocks may impair motor function, delaying rehabilitation. The iPACK block, targeting the posterior knee without affecting motor control, offers a promising alternative. This study aims to compare the effectiveness of two iPACK block approaches-proximal (at the distal femoral shaft) and distal (between the femoral condyles)-in managing postoperative pain in TKA patients. In a double-blind, randomized controlled trial with 120 participants, pain scores, opioid use, and time to rescue analgesia will be assessed. The hypothesis is that the distal iPACK block provides superior pain relief, potentially improving patient outcomes and recovery.
详细描述
Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic procedures in modern medicine. Despite advancements in surgical techniques and perioperative care, postoperative pain management remains a significant challenge and a key factor influencing time to mobilization, patient satisfaction, and length of hospital stay. Commonly used analgesic techniques, such as femoral nerve blocks or epidural analgesia, while effective, can impair motor function and thus delay rehabilitation.
To minimize motor deficits while still providing effective pain relief, newer regional anesthesia techniques have been introduced into clinical practice. One such technique is the iPACK block (interspace between the popliteal artery and posterior capsule of the knee), which targets the posterior knee - an area often insufficiently covered by conventional nerve blocks. This method involves administering a local anesthetic into the space between the popliteal artery and the posterior capsule of the knee joint, offering analgesia without significant motor impairment.
Originally, the iPACK block was described as being performed at the level of the distal femoral shaft, several centimeters above the femoral condyles. Recently, however, a more distal variation of the technique has emerged, where the anesthetic is injected directly between the femoral condyles. This may provide more effective coverage of the posterior knee capsule's innervation. To date, there are no randomized trials that directly compare the efficacy of the distal and proximal iPACK approaches in terms of postoperative pain as the primary outcome.
Our aim is to conduct a prospective, randomized, placebo-controlled, double-blind clinical trial to compare the effectiveness of the distal and proximal iPACK blocks in patients undergoing TKA. A total of 120 patients will be enrolled and randomly assigned to one of two groups.
- In the proximal iPACK group, participants will receive 20 ml of 0.25% levobupivacaine with adrenaline (1:200,000), injected at the level of the distal femoral shaft (a straight portion of the femur without the condyles).
- In the distal iPACK group, the same volume and concentration of anesthetic will be injected at the most distal part of the thigh, between the femoral condyles.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Patients undergoing primary unilateral total knee arthroplasty (TKA) for osteoarthritis
- •Ability to understand and sign informed consent
- •American Society of Anesthesiologists (ASA) classification I-III
- •Ability to cooperate and participate in postoperative pain assessments (e.g., VAS)
排除标准
- •Refusal to participate or failure to sign informed consent
- •Bilateral or revision TKA
- •Partial or unicondylar knee replacement
- •Severe knee deformity (flexion, varus, or valgus >30°)
- •Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, septic arthritis, post-traumatic arthritis)
- •Allergy to local anesthetics or any medications used in the study
- •Contraindications to regional anesthesia (e.g., infection at the injection site, coagulopathy, therapeutic anticoagulation)
- •BMI > 40 kg/m²
- •Severe renal impairment (KDIGO stage G4 or higher) or liver failure (Child-Pugh score ≥ 10)
- •Prior surgery or vascular procedure on the femoral vessels of the operated limb
- •Language barrier or inability to assess pain using the VAS
- •Planned outpatient (same-day discharge) procedure
研究组 & 干预措施
proximal iPACK group
In the proximal iPACK group, participants will receive 20 ml of 0.25% levobupivacaine with adrenaline (1:200,000), injected at the level of the distal femoral shaft (a straight portion of the femur without the condyles).
干预措施: proximal iPACK (Procedure)
distal iPACK group
In the distal iPACK group, the participants will receive 20 ml of 0.25% levobupivacaine with adrenaline (1:200,000), injected at the most distal part of the thigh, between the femoral condyles.
干预措施: distal iPACK (Procedure)
结局指标
主要结局
total opioids consumption
时间窗: from surgery until 24 hours after surgery
total opioids consumption calculated to MME (morphine milligrams equivalent)
次要结局
- time to first opioid administration(up to 24 hours after surgery)
- Visual analog scale 6 (rest)(6 hours postoperatively)
- Visual analog scale 12 (rest)(12 hours postoperatively)
- Visual analog scale 24 (rest)(24 hours postoperatively)
- Visual analog scale 6 (flexion)(6 hours postoperatively)
- Visual analog scale 12 (flexion)(12 hours postoperatively)
- Visual analog scale 24 (flexion)(24 hours postoperatively)