Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Postoperative analgesia
研究概览
简要总结
Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries
详细描述
After obtaining written informed consent from parents or guardians of all patients, 90 patients (6-12 years old) scheduled for abdominal surgeries operations will be included. Patients will be randomly allocated into three groups, 30 patients in each group. Randomization will be based on computer-generated codes maintained in sequentially numbered opaque envelopes.
Anesthetic Technique:
Anesthesia will be induced with Sevoflurane plus fentanyl (0.5µg/kg) and tracheal intubation will be facilitated with Rocuronium (0.4 mg/kg). Anesthesia will be maintained with Sevoflurane (will be adjusted according to A line autoregressive index (AAI)) and Rocuronium (0.1 mg/kg/dose will be given on the basis of train-of-four neuromuscular monitoring). ECG, noninvasive blood pressure, heart rate, temperature, oxygen saturation, and exhaled CO2 (end tidal CO2) will be continuously monitored during the procedure.
• After induction of anesthesia and before skin incision, a QLB will be performed in all patients in the three groups.
The procedure will be done under ultrasound guidance using curved array transducer 5-2MHz (Sonosite ultrasound system). Echogenic needle, Sono Plex Stim cannula (PAJUNK) 22 gauge and 60 mm length will be used. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The QLB block will be performed by anterior approach. The linear probe will be attached in the area of the triangle of Petit in transverse orientation in lateral abdomen in between the iliac crest and the costal margin, near the posterior axillary line. The muscle planes will be identified until visualizing the quadratus lumborum muscle, at the same plane as the psoas major muscle and the erector spinae. The needle tip is placed at the anterolateral border of the QL at its junction of QL with transversalis fascia outside the anterior layer of the thoracolumbar fascia (TLF) and fascia transversalis, and the local anesthetic will be injected.
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, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients(6-12 years)
- •ASA physical status I,II
- •Abdominal surgery
排除标准
- •Parents refusal or legal guardian's refusal
- •Allergy to bupivacaine or dexamethasone
- •Contraindications to regional techniques
- •Failed QLB
- •Infection on site of procedure
研究组 & 干预措施
Group B Quadratus Lumborum Block with dexamethasone locally
QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline
干预措施: Bupivacaine Injection (Drug)
Group A Quadratus Lumborum Block with dexamethasone IV
QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline
干预措施: ultrasound guided quadratus lumborum block (Procedure)
Group A Quadratus Lumborum Block with dexamethasone IV
QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline
干预措施: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously (Drug)
Group A Quadratus Lumborum Block with dexamethasone IV
QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline
干预措施: Bupivacaine Injection (Drug)
Group B Quadratus Lumborum Block with dexamethasone locally
QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline
干预措施: ultrasound guided quadratus lumborum block (Procedure)
Group B Quadratus Lumborum Block with dexamethasone locally
QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline
干预措施: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally (Drug)
Group C Quadratus Lumborum Block with bupivacaine alone
Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline.
干预措施: ultrasound guided quadratus lumborum block (Procedure)
Group C Quadratus Lumborum Block with bupivacaine alone
Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline.
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
Postoperative analgesia
时间窗: 24 hours
using the Pediatric Objective Pain Scale (15), where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia.
The duration of analgesia
时间窗: 24 hours
the time starting from extubation until analgesia will be required as evidenced by a pain score \> 4.
次要结局
- The total amount of paracetamol doses(24 hours)
- Postoperative vomiting(12 hours)
研究者
AHMED ABDELAZIZ SHAMA
Lecturer and consultant of anesthesia and surgical ICU
Tanta University