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临床试验/NCT07379866
NCT07379866招募中不适用

Ultrasound Guided Glossopharyngeal and Maxillary Nerve Blocks for Perioperative Pain Control in Adenotonsillectomy in Pediatrics: A Randomized Controlled Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Time to first rescue analgesia

研究概览

简要总结

This study aims to compare of bilateral ultrasound-guided glossopharyngeal nerve (UGGNB) and ultrasound-guided maxillary nerve (UGMNB) versus conventional multimodal analgesia for tonsillectomy operations.

详细描述

Patients will be premedicated with oral midazolam 0.5 mg/kg prior to arriving in the operating room 30 min before the procedure.

Standard monitoring will be maintained throughout the procedure included electrocardiography, noninvasive arterial pressure, arterial oxygen saturation.

. If intravenous access is present, Fentanyl 1 μg/kg IV will be given and anesthesia will be induced using propofol 2-3 mg/kg and atracurium 0.5 mg/kg. If intravenous access is not present, anesthesia will be induced with inhalation of 8% sevoflurane in 100% oxygen under spontaneous ventilation and IV access will be established, fentanyl 1 µg/kg IV and atracurium 0.5 m g/kg IV will be given after achieving IV access. Endotracheal intubation will be done using an appropriate size endotracheal tube (ETT) and capnography attached. IV dexamethasone 150 μg/kg will be given. Anesthesia will be maintained using a 50:50 mixture of air and oxygen along with isoflurane 1.2% and the maintenance dose of atracurium 0.1 mg/kg each 20 minutes. Pressure-controlled ventilation and low fresh gas flows will be used. All patients will receive intraoperative analgesia in the form of single dose paracetamol 15 mg/kg.

Patients will be randomly allocated into two equal groups:

Block Group: patients will receive combined bilateral ultrasound-guided glossopharyngeal nerve (UGGNB) and bilateral ultrasound-guided maxillary nerve (UGMNB) immediately after the induction of anesthesia and prior to surgical incision by an expert anesthesiologist in ultrasound guided regional anesthesia who is not a part of the study using Philips Model HD5 Diagnostic ultrasound system a the scanning probe will be the linear ultrasound probe (4-12MHz) for glossopharyngeal nerve block and a curvilinear ultrasound probe (5-7 MHz) for maxillary nerve block using fine needle as described with aid of ultrasound.

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)

盲法说明

Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. The study will be a single blinded trial where the assessor who follow the patients post-operatively is blinded to the technique given.

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients aged 5 to 13 years
  • American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy.

排除标准

  • Parents Refusal
  • Cognitive impairment or developmental delays.
  • Infection at injection site.
  • Recent upper respiratory tract infection.
  • Post-tonsillectomy bleeding, allergy to local anesthetics.
  • American Society of Anesthesiologists (ASA) class III and IV.
  • Morbid obesity.
  • Those receiving regular analgesia within the last week before surgery.

研究组 & 干预措施

Block Group

Active Comparator

patients will receive combined bilateral ultrasound-guided glossopharyngeal nerve (UGGNB) and bilateral ultrasound-guided maxillary nerve (UGMNB) immediately after the induction of anesthesia and prior to surgical incision

干预措施: ultrasound-guided glossopharyngeal nerve block (UGSGNB) (Procedure)

Block Group

Active Comparator

patients will receive combined bilateral ultrasound-guided glossopharyngeal nerve (UGGNB) and bilateral ultrasound-guided maxillary nerve (UGMNB) immediately after the induction of anesthesia and prior to surgical incision

干预措施: ultrasound-guided maxillary nerve (UGMN) (Procedure)

Conventional Group

Placebo Comparator

patients will receive multimodal analgesia for tonsillectomy operations in the form of single dose of IV paracetamol 15 mg/kg

干预措施: Placebo Block (Procedure)

结局指标

主要结局

Time to first rescue analgesia

时间窗: 24 hours

Time of the first claim for analgesia

次要结局

  • Heart rate(2 hours)
  • Intraoperative fentanyl consumption(2 hours)
  • Dietary intake(24 hours)
  • Postoperative pain scores(24 hours)
  • Total pethidine requirements(24 hours)
  • Post tonsillectomy bleeding.(24 hours)
  • Blood Pressure(2 hours)

研究者

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

Nagy Malak , MD

Principal investigator

Cairo University

研究点 (1)

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