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临床试验/NCT05023239
NCT05023239Unknown1 期

The Effect of Ultrasound-Guided Suprazygomatic Maxillary Nerve Block for Minimize the Post-operative Pain in Tonsillectomy Surgery

Cairo University0 个研究点目标入组 52 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
52
主要终点
postoperative Meperidine consumption

研究概览

简要总结

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion criteria
  • •Pediatric patients aged 4-12 years
  • •Genders eligible for study: both sexes
  • •ASA physical status I and II
  • •Undergoing tonsillectomy surgery

排除标准

  • •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.

研究组 & 干预措施

control group

Sham Comparator

patients will receive sham block by 10 ml of normal saline (5 mL in each side) as a control.

干预措施: UG-SZM Group (Other)

UG-SZM Group

Experimental

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

干预措施: UG-SZM Group (Other)

结局指标

主要结局

postoperative Meperidine consumption

时间窗: 24 hours

total dose of Meperidine consumption

次要结局

  • incidence of complication(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Cairo University

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