The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Reduction in dysphagia scores
研究概览
简要总结
The main objective of this study is to analyze the effects of local anesthetic application into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence rates in patients undergoing anterior cervical discectomy and fusion.
详细描述
The patients will be randomly assigned into one of the two groups to receive either bupivacaine hydrochloride 0.5% solution if they are randomized to the treatment group or 0.9% NaCl solution if they are randomized to the control group. These solutions will be poured into the retropharyngeal space intraoperatively before wound closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Patients older than 18 y.o.
- •Patients undergoing one- or two-level anterior cervical discectomy and fusion surgery for radiculopathy or myelopathy symptoms
- •Patients are wiling and able to sign informed consent and complete questionnaires
排除标准
- •More than 2-level ACDF surgeries
- •Previous cervical spine surgery
- •Surgeries for trauma, infection or tumor
- •Known hypersensitivity reactions to bupivacaine hydrochloride or other amino-amide anesthetics (e.g. lidocaine)
- •Known history of swallowing issues (e.g. dysphagia, odynophagia)
- •Pregnant or breastfeeding
研究组 & 干预措施
bupivacaine hydrochloride 0.5% solution
Bupivacaine hydrochloride 0.5% 10 mL solution poured into the retropharyngeal space intraoperatively before wound closure during anterior cervical discectomy and fusion procedure
干预措施: bupivacaine hydrochloride 0.5% solution (Drug)
0.9% NaCl solution
0.9% NaCl 10 mL solution poured into the retropharyngeal space intraoperatively before wound closureduring anterior cervical discectomy and fusion procedure
干预措施: 0.9% NaCl solution (Drug)
结局指标
主要结局
Reduction in dysphagia scores
时间窗: 3 months
Swallowing-Quality of Life Questionnaire
次要结局
未报告次要终点