NCT01975285已完成4 期
Prospective Randomized Double Blind Study to Evaluate the Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •60 patients (30 per group) undergoing foot and ankle procedures
- •Willingness and ability to sign an informed consent document
- •No allergies to anesthetic or analgesic medications
- •American Society of Anesthesiologists (ASA)physical status Class I - III
- •Aged 18-90 years,either sex
排除标准
- •Refusal to participate in the study
- •Age<18 or> 90 years -
- •Contraindications to regional blockage including but not limited to:
- •Patient refusal to regional blockade
- •Infection at the site of needle insertion
- •Systemic infection
- •Bleeding diathesis or coagulopathy
研究组 & 干预措施
Dexamethasone group
Active Comparator
Dexamethasone 4mg(1 ml) per 20cc
干预措施: Dexamethasone (Drug)
Saline group
Placebo Comparator
Saline 1 ml per 20cc
干预措施: Saline (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 3 days
Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain
次要结局
- Length of Analgesia(3 days)
- Patient Satisfaction With Pain Management(3 days)
- Patient Satisfaction With Regional Nerve Block(3 days)
- Opioid Consumption(3 days)
研究者
Roya Yumul, M.D.,PhD.
Residency program director, Department of anesthesiology
Cedars-Sinai Medical Center
研究点 (1)
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