Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft: A Single Center Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Opioid Utilization in First 24 Hours Post-Surgery
研究概览
简要总结
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft
详细描述
The protocol will determine if the addition of an IPACK block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing ACLR with Bone Patellar Tendon Bone Autograft
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 75 years of age
- •Patients undergoing primary ACL reconstruction with BPTB Autograft
- •ASA I or II
排除标准
- •Patients younger than 18 and older than
- •Patients with multi-ligament injury
- •Patients undergoing concomitant cartilage procedure or osteotomy.
- •Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
- •Patients who are allergic to oxycodone;
- •Patients with diagnosed or self-reported cognitive dysfunction;
- •Patients with a history of neurologic disorder that can interfere with pain sensation;
- •Patients with a history of drug or recorded alcohol abuse;
- •Patients who are unable to understand or follow instructions;
- •Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- •Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- •Patients with a BMI over 45;
- •Any patient that the investigators feel cannot comply with all study related procedures;
- •Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
研究组 & 干预措施
Participants receiving IPACK block
Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee.
干预措施: IPACK block (Drug)
结局指标
主要结局
Opioid Utilization in First 24 Hours Post-Surgery
时间窗: Up to Hour 24 Post-Operation
Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.
次要结局
- Patient-Reported VAS Scores at 48 Hours Post-Surgery(Hour 48 Post-Operation)
- Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery(Hour 24 Post-Operation)
- Patient-Reported VAS Scores at Day 7 Post-Surgery(Day 7 Post-Operation)
- Change in Tegner Activity Scale (TAS) Score(Baseline, Month 6 Post-Operation Visit)
- Change of Range of Motion (ROM) Assessment(Baseline, Month 6 Post-Operation Visit)
- Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)(Baseline, Month 6 Post-Operation Visit)
- Change in Kujala Scale Score(Baseline, Month 6 Post-Operation Visit)
- Patient-Reported VAS Scores at 72 Hours Post-Surgery(Hour 72 Post-Operation)
- Length of Stay in Post-Anesthesia Care Unit (PACU)(Up to Day 1 Post-Operation)