Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 主要终点
- Pain intensity
研究概览
简要总结
This is a randomized controlled study, aimed to investigate the effects of dinalbuphine sebacate (DS) on patients having uvulopalatopharyngoplasty (UPPP). DS is a prodrug of nalbuphine, a mixed agonist-antagonist opioid. The mean absorption time for the complete release of DS into systemic circulation is approximately 145 h, which could theoretically provide extended analgesic effects for up to 6 days. Patients diagnosed with obstructive sleep apnea are generally associated with higher risks towards opioid side effects, especially respiratory depression. Post-UPPP pain managing should be cautiously arranged and executed. We hypothesize that the combination of our routine practice and DS will improve the outcomes after Uppp.
详细描述
Within 4 weeks before uvulopalatopharyngoplasty, patients are invited for this study. After written informed consent gained, the eligibilities are checked. Eligible patients are arrogated into experimental or control group randomly prior to surgery. Experimental group receives the DS administration at least 12 hours before surgery. During peri-operative period, pain management are conducted following our routine practice. Pain intensity, consumption of analgesics, adverse events, swallow function and life quality are all assessed and recorded within 14 days after surgery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 20 and
- •diagnosed with obstructive sleep apnea.
- •arranged to undergo uvulopalatopharyngoplasty.
- •classified as ASA I, II, or III.
排除标准
- •can not comply with study protocol.
- •BMI > 34 kg/m
- •history of chronic pain.
- •history of narcotics or alcohol abuse.
- •allergic to NSAID.
- •diagnosed as diabetes mellitus with poor glycemic control.
- •diagnosed with severe cardiovascular or respiratory diseases.
- •judged as an unsuitable subject by investigators.
研究组 & 干预措施
Experimental group
Subjects will intragluteally injected with a dose of 150 mg dinalbuphine sebacate at least 12 hours before surgery. During intra- and post-operative period, the pain management will execute following our routine practice.
干预措施: Dinalbuphine sebacate (Drug)
Experimental group
Subjects will intragluteally injected with a dose of 150 mg dinalbuphine sebacate at least 12 hours before surgery. During intra- and post-operative period, the pain management will execute following our routine practice.
干预措施: Routine practice (Other)
Control group
The pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration.
干预措施: Routine practice (Other)
结局指标
主要结局
Pain intensity
时间窗: within 3 days after surgery
Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
次要结局
- Consumption of analgesics(within 14 days after surgery)
- Incidence of adverse events(within 14 days after surgery)
- MD Anderson Dysphagia Inventory(1 day, 3 days, 7 days and 14 days after surgery)
- Percentage of patients consuming analgesics(within 3 days after surgery)
- EAT-10 (Eating Assessment Tool)(1 day, 3 days, 7 days and 14 days after surgery)
- Pain intensity(within 14 days after surgery)
研究者
Li-Jen Hsin
Principal Investigator
Chang Gung Memorial Hospital