Pain After Total Knee Arthroplasty: a Comparison of Combined Continuous Adductor Canal Block With Infiltration of Local Anesthetic Between the Popliteal Artery and Capsule of the Knee Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Cumulative opioid consumption (morphine equivalents) in the first 24 hours
研究概览
简要总结
Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.
Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.
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, Care Provider)
盲法说明
Only the regional anesthesiologist performing the block will know the randomization status. The study participants, outcome assessors/researchers, other anesthesia personnel, surgeons, physician assistants, and nurses will be blinded to the treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral, primary tricompartment total knee arthroplasty
- •Age 18 years or older
- •ASA I-III
- •Eligible for spinal or combined spinal epidural anesthetic
- •Able to speak, read, and understand English
- •Willing to participate in the trial
排除标准
- •Contraindication to regional anesthesia or peripheral nerve blocks
- •Allergy to local anesthetics
- •Allergy to NSAIDs
- •Chronic renal insufficiency with Cr > 1.4 or GFR < 60
- •Have chronic pain that is not related to their knee joint
- •Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer)
- •Have a pre-existing peripheral neuropathy involving the operative site
- •Body mass index greater than or equal to 40
研究组 & 干预措施
continuous ACB with IPACK block
ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine
干预措施: Ropivacaine (Drug)
continuous ACB with sham subcutaneous saline injection
ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh
干预措施: Ropivacaine (Drug)
continuous ACB with sham subcutaneous saline injection
ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh
干预措施: Saline (Drug)
结局指标
主要结局
Cumulative opioid consumption (morphine equivalents) in the first 24 hours
时间窗: 24 hours
次要结局
- Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm(through study completion approximately 2 days)
- Walk distance on POD#1 am, POD#1 pm, POD#2(through study completion approximately 2 days)
- Hospital length of stay(through study completion approximately 2 days)
- Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score(through study completion approximately 2 days)
- Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room(through study completion approximately 2 days)
- Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm(through study completion approximately 2 days)
- Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey(through study completion approximately 2 days)
- Time to oral-only opioids(through study completion approximately 2 days)
- Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm(through study completion approximately 2 days)
- Pain location(through study completion approximately 2 days)
- Incidence of foot drop(through study completion approximately 2 days)
研究者
Matthew Patterson
Principal Investigator
Ochsner Health System