Prospective, Randomized, Controlled Clinical Trial to Evaluate Recovery From Post-operative Pain in Adults After Sleep Apnea Surgery Using a Coblation Device Compared to Electrocautery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
研究概览
简要总结
The purpose of this study is to assess whether tonsillectomy and UPPP performed using the study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection.
详细描述
This prospective clinical study is designed to assess whether tonsillectomy and UPPP performed using the study device to treat OSA symptoms in an adult population is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection. The amount of post-operative pain will be assessed daily over the 21-day post-operative recovery period using two general measures: 1) self-reported pain intensity and 2) self-reported pain medication administration, including frequency of use and dose. Further, timing of self-medication will be analyzed separately.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is > or = 18 years of age
- •Subject has positive diagnosis of Obstructive Sleep Apnea confirmed by polysomnographic study
- •Subject is a surgical candidate for UPPP and tonsillectomy with or without tongue base somnoplasty
- •Subject signs IRB-approved informed consent form
- •Subject is willing and able to complete required follow-up.
排除标准
- •Subject has had a previous tonsillectomy
- •Subject's RDI >40
- •Subject has a history of chronic use of narcotic pain medications
- •Subject is unable to take liquid opioid analgesics
- •Subject requires additional surgical procedures (such as nasal septoplasty or FESS) within 28 days of enrollment
结局指标
主要结局
Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
次要结局
- Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.
- Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
- Analysis of timing of self-administration of medication during the 21-day post-treatment period