甲哌卡因与布比卡因在超声引导踝关节阻滞中的起效时间
甲哌卡因与布比卡因超声引导下踝关节阻滞的感觉阻滞起效：一项随机非劣效性临床试验
The purpose of this research is to determine if both local anesthetics (mepivacaine and bupivacaine) are similar in their onset of sensory block to assess the efficiency of ultrasound-guided ankle blocks in our practice. Currently it is the standard of care to perform ankles blocks with both mepivacaine and bupivacaine. However, given similarity in their safety profile researchers would like to compare if one is non-inferior to the other in terms of onset time of ankle block.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age greater than or equal to 18 years old.
- Patients who provide informed consent to participate.
- Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia.
- ASA (American Society of Anesthesiology) Physical Status Classification I - III.
Exclusion Criteria:
- Inability to consent.
- Allergy to local anesthetic.
- Infection at site of injection.
- Pregnancy.
- Coagulopathy.
- Hepatic or renal failure.
- Preexisting neuropathy in operative limb.
- Planned spinal anesthetic or general anesthesia.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Mepivacaine group
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery |
Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves |
|
有源比较器：Bupivacaine group
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery |
Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Onset of sensory Blockage
大体时间：20 minutes
|
Time in minutes for successful surgical sensory blockade following the ankle block |
20 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Block Failure
大体时间：20 minutes
|
Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia |
20 minutes
|
|
Pain Scores
大体时间：Post-procedural, approximately 2-4 hours
|
Pain scores in post-anesthesia care unit (PACU) will be obtained using the numerical rating scale (0-10 point scale with 0 representing no pain and 10 representing the worst possible pain) |
Post-procedural, approximately 2-4 hours
|
|
Total opioid received intra-operatively
大体时间：Intra-operatively, approximately 4-6 hours
|
Total amount of opioid received intra-operatively |
Intra-operatively, approximately 4-6 hours
|
|
Time to first opioid use
大体时间：24 hours
|
Time measured in minutes to the first opioid use |
24 hours
|
|
Number of complications
大体时间：24 hour
|
Total number of procedural complications |
24 hour
|
|
Total anesthesia-related time
大体时间：20 minutes
|
Measured in minutes, defined as performance time plus onset time of local anesthesia |
20 minutes
|
|
Overall Benefit of Analgesia Score (OBAS)
大体时间：24 hours after discharge
|
Seven questions to access pain intensity, adverse effects and satisfaction with treatment. Possible score range from 0 to 24, with higher scores indicating worse outcome |
24 hours after discharge
|
|
Total opioid use after discharge
大体时间：24 hours after discharge
|
Total amount of opioids used used for pain control after discharge |
24 hours after discharge
|
|
Duration of the ankle block
大体时间：24 hours after discharge
|
Length of time measured in minutes the patient to felt until the ankle block completely wore off |
24 hours after discharge
|
合作者和调查者
赞助
调查人员
- 首席研究员：Bridget Pulos, MD、Mayo Clinic
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.