Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Post operative pain management
研究概览
简要总结
Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK.
The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.
排除标准
- •Revision ACLR, worker's compensation, pregnancy, age<18 years
研究组 & 干预措施
isolated adductor canal block (ACB) + IPACK
ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
干预措施: Infiltration between Popliteal Artery and Capsule of the knee (iPACK) (Procedure)
isolated adductor canal block (ACB)
Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.
干预措施: Bupivacaine HCl 0.5% Injectable Solution (Drug)
isolated adductor canal block (ACB)
Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.
干预措施: Dexamethasone (Drug)
isolated adductor canal block (ACB)
Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.
干预措施: Percocet 5Mg-325Mg Tablet (Drug)
isolated adductor canal block (ACB) + IPACK
ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
干预措施: Bupivacaine HCl 0.5% Injectable Solution (Drug)
isolated adductor canal block (ACB) + IPACK
ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
干预措施: Dexamethasone (Drug)
isolated adductor canal block (ACB) + IPACK
ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
干预措施: Percocet 5Mg-325Mg Tablet (Drug)
结局指标
主要结局
Post operative pain management
时间窗: 14 days
This will be measured by the participants completing a pain and medication Use questionnaire
Post operative pain management 2
时间窗: 6 months
Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires
次要结局
未报告次要终点