A Prospective Randomized Controlled Trial of Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Analgesic efficacy
研究概览
简要总结
This study is a randomized study that compares two commonly used post-operative pain reducing techniques by measuring the level of pain and use of pain medication after knee surgery.
详细描述
Post-operative pain is a commonly associated with knee surgery. Treatment often includes an oral or intravenous (IV) narcotic regimen which often leads to nausea, vomiting and can cause consti-pation. These issues can contribute to the overall discomfort of the post-operative patient. Intra-operative injections and local nerve blocks have become common adjuncts to narcotics to reduce post-operative pain and the necessity for oral or IV narcotic use. The aim of this study is to com-pare analgesic use and clinical effects on post-operative pain management with intra-articular in-jection of 20ccs of 2% lidocaine with epinephrine at the start of the case plus 20ccs 0.5% mar-caine with epinephrine at the end of the case vs. adductor canal saphenous nerve blockade in pa-tients undergoing knee arthroscopy, as indicated by the need for rescue narcotics and patient pain scores. A randomized, single blinded study will be performed to evaluate post-operative pain control using VAS scores at 1, 2, 4, 8, 12, 24, 36, and 48hrs post-operatively, rescue narcotic use in the PACU, and total narcotic consumption over the same time period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III patients
- •Age 18 to 65 years
排除标准
- •Allergy or intolerance to local anesthetics, NSAIDs, or opioids
- •Inability to understand the consent or study process
- •Any contraindication to regional anesthesia
- •Known history of substance abuse
- •Chronic home opioid therapy
- •History of major neurologic deficit in operative limb
- •Chronic pain syndromes
- •Pregnancy and nursing women
研究组 & 干预措施
Group A
Group A patients will receive their treatment at the completion of the case while under general anesthesia. The anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve.
Group A patients will receive placebo intra-articular and arthroscopic portal site saline injections equal in volume and procedure time point as the treatment in Group B.
At the completion of the case, the patient will be extubated and transferred to the PACU.
干预措施: Adductor Canal Block (Drug)
Group B
Group B will receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection. At the completion of the arthroscopic procedure the patient will receive an additional 20ccs of 0.5% marcaine with epinephrine intra-articular injection.
Group B patients will also receive 10ccs of 2% lidocaine with epinephrine injected superficially into each of the arthroscopic portal sites. Group B patients will receive a 15cc saline injection around the saphenous nerve under the same procedure as the adductor canal block for Group A.
At the completion of the case, the patient will be extubated and transferred to the PACU.
干预措施: Intra-articular Injection (Drug)
结局指标
主要结局
Analgesic efficacy
时间窗: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
VAS pain scores
Rescue narcotics use
时间窗: During post-surgical hospitalization
Opioid requirement due to pain
Total narcotic consumption
时间窗: During post-surgical hospitalization
Opioid requirement overall
次要结局
未报告次要终点