Is Lidocaine Useful Before Esophageal Manometry and Ambulatory pH Monitoring? A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Presence of pain during catheter insertion
研究概览
简要总结
A randomized controlled trial comparing esophageal manometry and ambulatory pH monitoring test tolerance in the presence versus in the absence of topical lidocaine.
详细描述
Conventionally, topical nasopharyngeal anesthesia is applied to improve the tolerance of esophageal manometry and ambulatory pH monitoring. However, there is currently no data to support this practice. This randomized controlled trial of lidocaine versus placebo applied before these tests will evaluate the benefit of topical lidocaine anesthesia.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing esophageal manometry or ambulatory pH monitoring at our center who are able to read and consent to participate in the study.
排除标准
- •Patients < 18 years
- •Incapacity to provide consent
- •History of lidocaine allergy
- •Current pregnancy
- •Previous esophageal manometry or ambulatory pH monitoring in the last 14 days
- •Previous participation in the study
- •Severe cirrhosis (Child-Pugh C)
- •Severe chronic kidney disease (eGFR<30 mL/min/1.73m2)
- •Severe heart failure (New York Heart Association Functional Classification 3-4)
- •Severe respiratory failure (dyspnea or oxygen-dependent at rest)
- •Any active severe incapacitating chronic or acute medical disease
- •Active hospitalization
- •Ulcerated, atrophic, infected or recently burned (in the last 30 days) nasopharynx
- •Recent surgery involving the nasopharynx (in the last 30 days)
- •Severe chronic pain (ex. regular daily use of opioids)
- •Previous stroke or any neurological lesion with resulting current sensory deficit
- •Major neurocognitive disorder
- •Any active severe incapacitating chronic or acute psychiatric disease
研究组 & 干预措施
Lidocaine
Patients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test.
干预措施: Lidocaine Hydrochloride (Drug)
Placebo (Saline)
Patients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test.
干预措施: Saline spray (Drug)
结局指标
主要结局
Presence of pain during catheter insertion
时间窗: Assessed once immediately after exam on patient questionnaire
As reported by patients on a standardized questionnaire
次要结局
- Global patient satisfaction(Assessed once immediately after exam on patient questionnaire)
- Presence of other complications during catheter insertion(Assessed once immediately after exam on patient questionnaire)
- Presence of complications during test recording(Assessed once immediately after exam on patient questionnaire)