The Anesthetic and Analgesic Effectiveness of Single Paravertebral Blockade Injection for Herniorrhaphy in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Analgesic consumption
研究概览
简要总结
Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable, timely and effective technique generates the investigation of a single PVB injection for children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind this investigation. First, possible spread of single PVB injection in the lumbar area over dermatomes corresponding to the inguinal hernia region in children likewise the spread over multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves, all three arising from L1-L2 level; thus, a single PVB injection at this level could provide unilateral segmental anesthesia.
详细描述
The study will be conducted prospectively, using a randomized double-blinded design. Male patients scheduled for elective unilateral herniorrhaphy will be included in the study.
Patients will be randomly allocated into two groups using the sealed envelope technique. All patients will have inhaled induction of anesthesia by facemask using oxygen and 8% sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained until completion of surgery.
Then, group I will receive one PVB injection at L1-L2 and placebo PVB injections at T12-L1 and L2-L3. Group III will receive three PVB injections at T12-L1, L1-L2 and L2-L3.
Paravertebral block technique After induction of anesthesia and placement of regular anesthetic monitors, three unilateral PVBs will be performed with the child lying in the lateral position with the operative side uppermost. The needle insertion sites will be 1.5-2.0 cm lateral to the midline depending on the age and the body mass index of the child.
After aseptic preparation of the skin, a nerve stimulator (Stimuplex, B Braun AG, Melsungen, Germany) is used to identify an evoked muscular contraction appropriate for the levels. A 50 mm 21G insulated needle (Stimuplex A, B Braun AG) will be introduced perpendicular to the skin using 5 mA and 1 Hz. Then, the stimulating needle is gently manipulated to allow for adequate muscle response with a stimulating current of 0.4-0.6 mA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 7 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •elective unilateral herniorrhaphy
排除标准
- •history of allergic reactions to local anesthetics
- •bleeding diatheses
- •spinal abnormality
结局指标
主要结局
Analgesic consumption
时间窗: 24 hours postoperatively
Analgesics consumed will be recorded
次要结局
- Hemodynamic stability(During the operation (approximately one hour))
研究者
Zoher Naja
Chairperson of Anesthesia and Pain Management Department
Makassed General Hospital