跳至主要内容
临床试验/NCT03401450
NCT03401450已完成4 期

Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
69
试验地点
1
主要终点
Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents

研究概览

简要总结

This is a prospective, randomized, single blinded trial involving human subjects. The goal of this study is to determine an optimal location (proximal or distal) for the nerve block and whether it will make a difference in how much opioid the patient will receive during and after surgery. Ultrasound will identify the adductor canal and the proximal end of the adductor canal/apex of the femoral triangle to determine the location of the blocks.

Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc

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

入选标准

  • Patients undergoing unilateral, ACL surgery with allograft.
  • Patients who consent to be randomized.
  • Patients must be English proficient.

排除标准

  • Patients younger than 18 or older than 75 years of age;
  • Patients with a history of chronic pain or who are taking medications intended to treat chronic pain such as strong opioids;
  • Patients with history of neurologic disorder that can interfere with pain sensation;
  • Patients with a history of drug or alcohol abuse;
  • Patients who are unable to understand or follow instructions;
  • Patients with an allergy or a contraindication to any of the medications used in the study, or patients with a contraindication to any of the study procedures;
  • Patients with severe liver disease, renal insufficiency, congestive heart failure, and/ or significant heart disease;
  • Patients with a BMI over 42;
  • Any patient that the investigators feel cannot comply with all study related procedures.
  • Patients who do not tolerate Percocet.

研究组 & 干预措施

ACB within true AC with bupivacaine

Active Comparator

The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine

干预措施: ACB within true AC with bupivacaine 0.5% 20cc (Drug)

ACB proximal to true AC with bupivacaine

Active Comparator

The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine

干预措施: ACB proximal to true AC with bupivacaine 0.5% 20cc (Drug)

结局指标

主要结局

Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents

时间窗: 24 Hours

Amount of morphine equivalents administered intraoperatively in 24 hours

Side Effects Such as Nausea, Itching, Constipation.

时间窗: 24 hours

Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents

时间窗: 24 Hours

Amount of morphine equivalents administered postoperatively in 24 hours

次要结局

  • Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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