Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS) Pain Scores
研究概览
简要总结
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
详细描述
Total knee arthroplasties (TKA) are severely painful surgeries that require optimal pain control to ensure expeditious recovery and discharge. Nerve blocks, such as the femoral and sciatic nerves, are instrumental in effectively providing pain relief and improving patient satisfaction. However, though pain scores notably decreased with the introduction of nerve blocks, motor blockade rendered these patients immobile and may pose a fall risk early in the post-operative period. The advent of ultrasound introduces newer block techniques with adequate analgesia without the cost of motor blockade.
The adductor canal block serves as an alternative to the femoral or sciatic nerve blocks in providing anterior knee analgesia without significantly compromising quadriceps strength. However, patients' posterior knee compartment remains an issue for pain control. Sciatic and posterior tibial nerve blocks were implemented but again, results in motor blockade. A small percentage of sciatic nerve block cases also exhibit foot drop due to peroneal nerve injury. Alternatively, as a sensory block, the periarticular injection (PAI) proves to hasten ambulation and recovery after TKA. The PAI blind injection into the posterior capsule seems to aid in pain control of the posterior compartment and reduces the total number physical therapy sessions.
Injection in the interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) provides an alternative to the PAI blind technique for analgesia in the posterior compartment. The IPACK block is not a nerve block, but rather infiltrates the area between the popliteal artery and femur. This area is rich with sensory nerve fibers from the posterior capsule of the knee, which originates from the sciatic and posterior tibial nerve. In this prospective study, we will compare pain scores between the three groups: ACB/PAI/IPACK, ACB/IPACK and PAI only. We will determine whether there is a difference between groups in NRS pain score with ambulation 24 hours post block administration.
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
- •Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
- •Age 18 to 80 years
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •English speaking (secondary outcomes include questionnaires validated in English only)
- •Patients of participating surgeons
排除标准
- •Hepatic or renal insufficiency
- •Younger than 18 years old and older than 80
- •Patients undergoing general anesthesia
- •Allergy or intolerance to one of the study medications
- •BMI > 40
- •ASA of IV
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
- •Patients with severe valgus deformity and flexion contracture
研究组 & 干预措施
Peri-Articular Injections only
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.5% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
-
20cc 0.25% bupivacaine
-
2 mg IV dexamethasone.
干预措施: Bupivacaine with epinephrine (Drug)
Peri-Articular Injections only
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.5% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
-
20cc 0.25% bupivacaine
-
2 mg IV dexamethasone.
干预措施: Methylprednisolone (Drug)
Peri-Articular Injections only
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.5% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
-
20cc 0.25% bupivacaine
-
2 mg IV dexamethasone.
干预措施: Cefazolin (Drug)
Peri-Articular Injections only
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.5% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
-
20cc 0.25% bupivacaine
-
2 mg IV dexamethasone.
干预措施: 8 MHz. Chiba needle (Device)
Peri-Articular Injections only
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.5% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
-
20cc 0.25% bupivacaine
-
2 mg IV dexamethasone.
干预措施: Bupivacaine 25cc (Drug)
Peri-Articular Injections only
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.5% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
-
20cc 0.25% bupivacaine
-
2 mg IV dexamethasone.
干预措施: Bupivacaine 20cc (Drug)
Peri-Articular Injections only
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.5% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
-
20cc 0.25% bupivacaine
-
2 mg IV dexamethasone.
干预措施: Dexamethasone (Drug)
Peri-Articular Injections, Adductor Canal Block, and IPACK
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.25% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
干预措施: Bupivacaine with epinephrine (Drug)
Peri-Articular Injections, Adductor Canal Block, and IPACK
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.25% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
干预措施: Methylprednisolone (Drug)
Peri-Articular Injections, Adductor Canal Block, and IPACK
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.25% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
干预措施: Cefazolin (Drug)
Peri-Articular Injections, Adductor Canal Block, and IPACK
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.25% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
干预措施: 8 MHz. Chiba needle (Device)
Peri-Articular Injections, Adductor Canal Block, and IPACK
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.25% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
干预措施: Bupivacaine with Dexamethasone (Drug)
Peri-Articular Injections, Adductor Canal Block, and IPACK
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.25% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
干预措施: Bupivacaine 25cc (Drug)
Peri-Articular Injections, Adductor Canal Block, and IPACK
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
-
Injection prior to cementation
-
bupivacaine 0.25% with epinephrine 30cc;
-
methylprednisolone, 40 mg/ml, 1 ml
-
cefazolin, 500 mg in 10 ml
-
normal saline, 22cc
-
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation)
a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
干预措施: Bupivacaine 20cc (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) Pain Scores
时间窗: 24 hours post block administration
Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration. Min = 0, no pain Max = 10, worst imaginable pain
次要结局
- Opioid Consumption(24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3)
- Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement(24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3)
- Ambulation Distance During Physical Therapy(It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3)
- Level of Patient Satisfaction With Postoperative Pain Management(Post-Operative Day 2)
- Pain Outcomes(Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported)
- Hospital Length of Stay(Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3)
- Opioid Related Symptom Distress Scale (ORSDS)(Post-Operative Day 1 and Post-Operative Day 2)
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)(Measured at pre-operation (day of surgery) and 6 weeks post-operation)