Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group
研究概览
简要总结
Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia.
- •Adult, 19 years of age and older.
- •Subject classified as American Society of Anesthesiology (ASA) class 1, 2, or
- •The ASA defines these statuses as follows: 1-A normal healthy patient. 2-A patient with mild systemic disease. 3-A patient with severe systemic disease.
排除标准
- •Any subject not classified as an ASA 1, 2, or
- •Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone.
- •Subject with a history of continuous opioid use for greater than one month prior to surgery.
- •Pre-existing neurologic deficit in lower extremity (surgical site).
- •Clinically significant coagulopathy (hemophilia, von Willebrand disease).
- •Patients who fail to follow the UAB Department of Anesthesiology Algorithm for the Preoperative Management of an Angiotensin Converting Enzyme Inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB). A copy of the algorithm can be found in Appendix
研究组 & 干预措施
Clonidine and Ropivacaine
A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
干预措施: Clonidine (Drug)
Clonidine and Ropivacaine
A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
干预措施: ropivacaine (Drug)
Ropivacaine
Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine
干预措施: ropivacaine (Drug)
结局指标
主要结局
Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group
时间窗: baseline to 72 hours
Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group
时间窗: baseline to 72 hours
Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
次要结局
- Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo(baseline to discharge from hospital (expected 3 days))
- the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.(baseline to discharge (approximately 72 hours))
- Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.(baseline to 24 hours post block)
- Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group(baseline to 24 hours post block)
- Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group(baseline to 24 hours post block)
- Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group(baseline to 24 hours)
研究者
Promil Kukreja
Principal Investigator
University of Alabama at Birmingham