Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Duration of Sensory Nerve Block
研究概览
简要总结
This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.
详细描述
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elective robotic medial MAKO partial knee arthroplasty
- •agreed to a regional anesthesia technique
排除标准
- •contraindications to regional anesthesia
- •presence of a progressive neurological deficit
- •a pre-existing coagulopathy, infection
- •insulin and non-insulin dependent diabetes mellitus
- •systemic use of corticosteroids within 30 days of surgery
- •chronic use of an opioid analgesic (>3 months or a combined total of more than 40 mg Oxycodone equivalents a day)
- •pregnancy
- •a prior history of an adverse event (for example: psychosis) or an allergy to dexamethasone
研究组 & 干预措施
4 mg Perineural Dexamethasone Group
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Dexamethasone (Drug)
4 mg Perineural Dexamethasone Group
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Bupivacaine (Drug)
4 mg Perineural Dexamethasone Group
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Epinephrine (Drug)
4 mg Perineural Dexamethasone Group
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Saphenous Peripheral Nerve Block (Procedure)
1 mg Perineural Dexamethasone Group
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Dexamethasone (Drug)
1 mg Perineural Dexamethasone Group
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Bupivacaine (Drug)
1 mg Perineural Dexamethasone Group
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Epinephrine (Drug)
1 mg Perineural Dexamethasone Group
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
干预措施: Saphenous Peripheral Nerve Block (Procedure)
Placebo Group
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
干预措施: Bupivacaine (Drug)
Placebo Group
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
干预措施: Epinephrine (Drug)
Placebo Group
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
干预措施: Saphenous Peripheral Nerve Block (Procedure)
结局指标
主要结局
Duration of Sensory Nerve Block
时间窗: 12 to 48 hours
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.
次要结局
- Rate of Post Operative Nausea and Vomiting(0 to 30 hours)
- Verbal Pain Scores(0 to 30 hours)
- Post Operative Opioid Use and Consumption(0-30 hours)
- Time to First Opioid Analgesic Request(0 to 36 hours)
- Neurologic Complications(throughout study completion, up to 48 hours)