Ultrasound Guided Glossopharyngeal and Maxillary Nerve Blocks for Perioperative Pain Control in Adenotonsillectomy in Pediatrics: A Randomized Controlled Trial.
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
- 是
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
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
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
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
Nagy Malak , MD
Principal investigator
Cairo University
