Analgesic Effect of Fascia Transversalis Block Versus Transversus Abdominal Plane Block in Children Undergoing Open Inguinal Hernia Surgery. A Randomized Comparative Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time to First need of analgesia
研究概览
简要总结
Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block.
详细描述
All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time Intra-operative management Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will be followed by insertion of intravenous (I.V) cannula.
General anesthesia will be induced in supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal intubation will then follow by appropriate size of endotracheal tube. Volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.
The Block will be performed using Sonosite S-Nerve Portable Ultrasound and SLAX/13-6 MHZ transducer will be used. 0.4 ml/kg bupivacaine 0.25% will be installed in the block plane. After receiving the block, surgical incision will be allowed to be done after 15 minutes.
Continuous recording of heart rate, blood pressure, will be carried out from the moment of injection at timely intervals intra-operative.
Increase of HR BP. >30% of baseline Indicates failure of block so fentanyl will be given at 1 mic / kg intra-operative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II
排除标准
- •Parents' refusal to participate in the study.
- •Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR> 1.5).
- •Localized infection at the site of needle insertion.
- •Known hypersensitivity or allergies to any of the used drugs.
研究组 & 干预措施
Group A
Patients will receive fascia transversalis block
干预措施: Ultrasound- guided Fascia Transversalis plane block (Procedure)
Group A
Patients will receive fascia transversalis block
干预措施: Fentanyl (Drug)
Group A
Patients will receive fascia transversalis block
干预措施: Pethidine (Drug)
Group A
Patients will receive fascia transversalis block
干预措施: Acetaminophen (Drug)
Group B
Patients will receive Transversus abdominus plane block
干预措施: Fentanyl (Drug)
Group B
Patients will receive Transversus abdominus plane block
干预措施: Acetaminophen (Drug)
Group B
Patients will receive Transversus abdominus plane block
干预措施: Ultrasound-guided Transversus abdominus plane block (Procedure)
Group B
Patients will receive Transversus abdominus plane block
干预措施: Pethidine (Drug)
结局指标
主要结局
Time to First need of analgesia
时间窗: First 6 hours postoperative
time (minutes) to First need of rescue analgesia
次要结局
- Total Pethidine Consumption(First 6 hours postoperative)
- Postoperative pain assessment FLACC(First 6 hours postoperative)
研究者
maged gamal
Anesthesia lecturer
Kasr El Aini Hospital