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临床试验/NCT02024724
NCT02024724已完成4 期

Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.

Northwestern University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年11月最近更新:
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
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

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

Active Comparator

4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine

干预措施: Bupivacaine (Drug)

Dexamethasone

Active Comparator

4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine

干预措施: Dexamethasone (Drug)

Triamcinolone

Active Comparator

40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine

干预措施: Bupivacaine (Drug)

Triamcinolone

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antoun Nader

Professor of Anesthesiology

Northwestern University

研究点 (1)

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