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临床试验/NCT01939379
NCT01939379撤回不适用

Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine

Loma Linda University1 个研究点 分布在 1 个国家开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Total Opiate pain medication

研究概览

简要总结

The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is the subject undergoing primary unilateral total knee arthroplasty?
  • Is the subject 18 to 99 years of age?
  • Is the subject ASA class 1, 2, or 3?
  • Does the subject have a BMI less than 35?
  • Can the subject consent in the English language?

排除标准

  • Does subject have an allergy to drugs used in this study;
  • Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
  • Does subject have a history of alcohol or drug abuse
  • Has subject had a previous total knee arthroplasty?
  • Has subject had any neurologic deficits in the lower extremity being studied?

研究组 & 干预措施

15ml ropivacaine

Active Comparator

Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours

干预措施: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. (Drug)

30ml ropivacaine

Active Comparator

If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours.

干预措施: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA. (Drug)

结局指标

主要结局

Total Opiate pain medication

时间窗: The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.

At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome

次要结局

  • Patient satisfaction with pain control(We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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