Efficacy of Regional Adductor Canal Block Using Extended Release Liposomal Bupivacaine in Total Knee Arthroplasty: A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Difference in mean pain scores in the first 3 days after surgery
研究概览
简要总结
Pain management after total knee arthroplasty is essential for optimized clinical outcomes and higher satisfaction. Exparel (Pacira Pharmaceuticals, Parsippany, New Jersey, USA) is a long-acting Bupivacaine extended release liposome compound that is injected peri-articularly or as regional block. The purpose of this study was to compare the analgesic efficacy of single administration of Exparel for local peri-articular infiltration versus adductor canal regional block.
详细描述
Multimodal pain approach is now an accepted standard of care to improve pain, enable earlier mobilization and faster recovery, decreased length of stay, and reduce opioid consumption and related side effects. The multimodal approach includes peri-operative oral and IV analgesics, local periarticular injections (PAI), and/or regional blocks such as femoral nerve blocks nerve or subsartorial saphenous nerve (adductor canal) blocks. Extended release bupivacaine (Exparel - Pacira Pharmaceuticals, Parsippany, NJ, USA) in liposomal form was developed for longer lasting post-operative analgesia. There are limited studies analyzing its efficacy of single injection liposomal bupivacaine in adductor canal block in total knee arthroplasty. The investigators hypothesized that a single adductor canal regional block injection would provide similar pain relief as peri-articular infiltration of Exparel.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary knee osteoarthritis undergoing unilateral knee replacement
排除标准
- •hypersensitivity and/or allergies to local anesthetics or previous knee surgery
研究组 & 干预措施
Adductor block protocol
An ultrasound-guided injection of Subsartorial saphenous nerve using Exparel 266 mg (20 cc vial) via a 21-gauge 4-inch Stimuplex A needle (B. Braun Medical Inc., Melsungen, Germany) was performed at mid-thigh level with a high-frequency linear ultrasound transducer. All regional anesthesia was performed by a trained anesthesiologist. Ultrasound pictures (pre-injection and post-injection) was obtained to verify proper local anesthetic placement.
干预措施: Exparel (Drug)
Adductor block protocol
An ultrasound-guided injection of Subsartorial saphenous nerve using Exparel 266 mg (20 cc vial) via a 21-gauge 4-inch Stimuplex A needle (B. Braun Medical Inc., Melsungen, Germany) was performed at mid-thigh level with a high-frequency linear ultrasound transducer. All regional anesthesia was performed by a trained anesthesiologist. Ultrasound pictures (pre-injection and post-injection) was obtained to verify proper local anesthetic placement.
干预措施: Adductor block protocol (Procedure)
peri-articular injection
Peri-articular injection included combination of Exparel 266 mg (20 ml vial) with 20 ml of 0.5% bupivacaine, and normal saline to a total volume of 120 ml. The injection was meticulously administered prior and after cementation in the posterior capsule, posteromedial structures, the periarticular synovium, extensor apparatus, pes anserinus, anteromedial capsule, periosteum, iliotibial band, and subcutaneous plane. Injections were performed using 20-mL syringes with 22-gauge needle, minimal leakage. Visible tissue expansion was achieved.
干预措施: Exparel (Drug)
peri-articular injection
Peri-articular injection included combination of Exparel 266 mg (20 ml vial) with 20 ml of 0.5% bupivacaine, and normal saline to a total volume of 120 ml. The injection was meticulously administered prior and after cementation in the posterior capsule, posteromedial structures, the periarticular synovium, extensor apparatus, pes anserinus, anteromedial capsule, periosteum, iliotibial band, and subcutaneous plane. Injections were performed using 20-mL syringes with 22-gauge needle, minimal leakage. Visible tissue expansion was achieved.
干预措施: peri-articular injection protocol (Procedure)
结局指标
主要结局
Difference in mean pain scores in the first 3 days after surgery
时间窗: 3 days
Pain was recorded during the first 3 post-operative days after surgery on scale 0 to 10 (visual analog scale). Zero represents 'no pain', as the best outcome and 10 represents as 'the worst pain experienced' as the worst outcome.The difference between the mean pain score in the two groups is assessed.
次要结局
- Difference in mean opioid consumption in the first 3 days after surgery(3 days)
研究者
Morteza Meftah
Chief, Adult Recosntruction Orthopaedic Surgery
Bronx-Lebanon Hospital Center Health Care System