Ultrasound Guided Adductor Canal Block vs Intra-Operative Trans-Articular Saphenous Nerve Block: A Prospective Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Narcotic Consumption
研究概览
简要总结
The investigators will be comparing the efficacy of two different techniques for performing an adductor canal block to the saphenous nerve as a part of the multimodal pain control regimen for total knee arthroplasty. The investigators will be comparing a "low adductor canal block" in which the surgeon administers local anesthetic to the distal aspect of the nerve from the operative site to a "high adductor canal block" in which the anesthesiologist administers the local anesthetic more proximally along the thigh using ultrasound guidance. The investigators will power the study for non-inferiority to compare the newer "low" block to the more commonly performed and more widely studied "high" block.
详细描述
Study Design: Prospective RCT
Study Question- Does a surgeon administered intra-operative adductor canal block ("Low-ACB") provide non-inferior post-operative pain relief relative to anesthesia administered, ultrasound guided adductor canal block ("High-ACB").
Hypothesis- Surgeon administered Low-ACB provides non-inferior pain relief relative to anesthesia administered High-ACB.
Study Groups-
- US Guided, Anesthesia Administered Adductor Canal Block ("High ACB")
- Intra-Operative, Surgeon Administered Adductor Canal Block ("Low ACB")
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
- None
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
- •All patients undergoing unilateral primary TKA for primary osteoarthritis
- •Age over 18
排除标准
- •Pre-operative narcotic use
- •Bilateral procedure
- •Non-Primary arthroplasty
- •Workman's comp
- •Inability to have spinal anesthesia (blood thinners)
- •Unsuccessful spinal anesthesia
- •Inflammatory or Post Traumatic arthritis
- •ASA score of 4
- •Pregnancy
研究组 & 干预措施
High ACB
In the pre-operative cohort, the adductor canal block is administered by anesthesia staff immediately prior to patient transport to the operating room. The thigh is prepped with cholorhexidine at the midpoint between the anterior superior iliac spine and the patella and sterile drapes are applied. An ultrasound probe is then used to localize the adductor canal and confirm that the femoral artery, femoral vein and saphenous nerve can be visualized deep to the sartorious. The probe is moved proximally or distally until the neurovascular bundle is centered under the sartorius. A 20cc syringe with a blunt tip 1.5in 18ga needle is then used to inject 15cc of 0.5% ropivocaine. Following this, the wound is prepped and draped in usual sterile fashion for the arthroplasty procedure.
干预措施: Ropivacaine (Drug)
Low ACB
Surgeon Administered Group In the intra-operative cohort, the block will be administered after the final components are in place and cement debris is removed. The knee joint is irrigated with dilute hibiclens or betadine followed by pulsatile lavage per institutional protocol. A blunt tip 1.5in 18ga needle was then used to administer 15cc of 0.5% ropivocaine.. The location of the saphenous nerve as it exits the adductor canal will be estimated to be 1.5x the TEA proximal to the medial epicondyle in men and 1.3x the TEA proximal in women as described by Kavolus et al. The 60cc of the anesthetic will then injected through the vastus medialis musculature in a field extending from 1cm proximal to one cm distal to the assumed location of the nerve with the needle directed in from 20° to 45° medial. The wound is then irrigated pulsatile lavage one final time and closed in layered fashion.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Narcotic Consumption
时间窗: through study completion, an average of 6 weeks
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
次要结局
- Length of stay(through study completion, an average of 6 weeks)
- Visual Analog Scale Pain Scores(Recorded hourly while in hospital, daily after discharge up until 6wks)
- Inpatient therapy(Up to 48 hours after surgery)
- Patient Reported Outcome Measure Information System 10 Score(through study completion, an average of 6 weeks)
- Knee injury and Osteoarthritis Outcome Score Junior(through study completion, an average of 6 weeks)
- Range of Motion(through study completion, an average of 6 weeks)