Onset of Sensory Blockade in Ultrasound-Guided Ankle Block With Mepivacaine Versus Bupivacaine: A Randomized Non-Inferiority Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Onset of sensory Blockage
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, the anesthesiologist performing the block and assessing the block efficacy over time will all be masked as to which local anesthetic is being used
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Mepivacaine group
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery
干预措施: Mepivacaine (Drug)
Bupivacaine group
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Onset of sensory Blockage
时间窗: 20 minutes
Time in minutes for successful surgical sensory blockade following the ankle block
次要结局
- Block Failure(20 minutes)
- Pain Scores(Post-procedural, approximately 2-4 hours)
- Total opioid received intra-operatively(Intra-operatively, approximately 4-6 hours)
- Time to first opioid use(24 hours)
- Number of complications(24 hour)
- Total anesthesia-related time(20 minutes)
- Overall Benefit of Analgesia Score (OBAS)(24 hours after discharge)
- Total opioid use after discharge(24 hours after discharge)
- Duration of the ankle block(24 hours after discharge)
研究者
Bridget P. Pulos
Principal Investigator
Mayo Clinic