The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.
详细描述
The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, 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 with total or partial tonsillectomy with or without adenoidectomy
排除标准
- •patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma
- •patients who have diabetes
- •patients who have bleeding problems
- •patients who are suspected to have signs of acute pharyngeal infection
研究组 & 干预措施
Infiltration
Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
干预措施: Infiltration (Other)
Infiltration
Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
干预措施: General anesthesia (Other)
Placebo
Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.
干预措施: Placebo (Other)
Placebo
Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.
干预措施: General anesthesia (Other)
结局指标
主要结局
Post operative pain
时间窗: within 10 days after the operation
Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.
次要结局
- PONV(within 10 days after the operation)
研究者
Zoher Naja
Anesthesiologist
Makassed General Hospital