Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change of Pain Score
研究概览
简要总结
Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain & ENT clinic visit
排除标准
- •age <18 or >80
- •pregnant women
- •economically disadvantaged (not able to afford clinic visits/treatments)
- •decisionally impaired (unable to obtain informed consent)
- •has allergy to bupivacaine
- •unable or unwilling to participate plans to participate in another clinical study at any time during this study
研究组 & 干预措施
Exparel
Patients receive an endoscopically guided injection of Exparel (Bupivacaine).
干预措施: Exparel (Bupivacaine Liposome) (Drug)
Saline
Patients receive an endoscopically guided injection of saline
干预措施: Saline (Drug)
结局指标
主要结局
Change of Pain Score
时间窗: Baseline to day 21
Scores range from 0-10 (0=no pain, 10=worst pain)
次要结局
- Change of Associated Symptoms(Baseline to day 21)
研究者
Peter Hwang
PROFESSOR OF OTOLARYNGOLOGY - HEAD & NECK SURGERY (OHNS) AND, BY COURTESY, OF NEUROSURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER
Stanford University