Ultrasound-Guided Suprazygomatic Maxillary Nerve Block as A Part of Multimodal Analgesic Regimens
The Effect of Ultrasound-Guided Suprazygomatic Maxillary Nerve Block for Minimize the Post-operative Pain in Tonsillectomy Surgery
Inadequate peri-operative analgesia may contribute to an increased risk of bleeding, suture dehiscence and unacceptable surgical outcomes. Moreover, these patients are at high risk of postoperative airway obstruction and respiratory failure.
Opioids may contribute to these complications. Appropriate use of regional anaesthesia may mitigate or eliminate many of these concerns. The maxillary nerve is responsible for the sensory innervation of the midface, including the hard and soft palates, upper jaw, upper dental arch and upper lip.Recently, the successful use of maxillary nerve block by the suprazygomatic approach has been reported in children undergoing cleft palate surgery. However, the use of this block has not been described in large series of patients, and the effectiveness of the suprazygomatic approach has not been evaluated in patients undergoing tonsillectomy .
研究概览
研究类型
注册 (预期的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名：amr wahdan, MD
- 电话号码：01001422499
- 邮箱：amr_amw010@hotmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria
- Pediatric patients aged 4-12 years
- Genders eligible for study: both sexes
- ASA physical status I and II
Undergoing tonsillectomy surgery
Exclusion criteria
- Parents' refusal
- Contraindications to regional anesthesia
- Known allergy to local anesthetics
- Bleeding disorders
- Children with diabetes mellitus, obstructive sleep apnea syndrome, cardiac, renal, liver or blood diseases, swallowing disorders or peritonsillar abscess,
- Children receiving regular analgesia within the last week before surgery,
- Children undergoing simultaneous procedure in the field of surgery like adenoidectomy or tongue tie will be all excluded from the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
假比较器：control group
patients will receive sham block by 10 ml of normal saline (5 mL in each side) as a control.
|
The patients will be receive Ultrasound-Guided Suprazygomatic Maxillary Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine .
|
|
实验性的：UG-SZM Group
The patients will be receive bilateral Ultrasound-Guided Suprazygomatic Maxillary (UG-SZM) Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine
|
The patients will be receive Ultrasound-Guided Suprazygomatic Maxillary Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine .
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
postoperative Meperidine consumption
大体时间：24 hours
|
total dose of Meperidine consumption
|
24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
incidence of complication
大体时间：24 hours
|
postoperative complication
|
24 hours
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- n-2021
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
UG-SZM Group的临床试验
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
-
Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的
-
Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的