Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.
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
- The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
研究概览
简要总结
Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine.
Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting to the Northwestern Pain Center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block.
排除标准
- •Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.
研究组 & 干预措施
Dexamethasone
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
干预措施: Bupivacaine (Drug)
Dexamethasone
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
干预措施: Dexamethasone (Drug)
Triamcinolone
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
干预措施: Bupivacaine (Drug)
Triamcinolone
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
干预措施: Triamcinolone (Drug)
结局指标
主要结局
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
时间窗: 2 weeks
The number of subjects reporting a minimum of 50% pain relief after receiving the injection.
次要结局
未报告次要终点
研究者
Antoun Nader
Professor of Anesthesiology
Northwestern University
