The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to first request of opioid analgesia
研究概览
简要总结
Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage , inadequate intraoperative pain assessment and management.
Axillary nerve block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so it can be conducted with upper limb orthopedic surgery in hand, rest and elbow surgery distal to the cubital fossa.Sensory blockade of the brachial plexus for perioperative analgesia leads to stable haemodynamics intraoperatively, smoother emergence from general anaesthesia and decreased need for supplemental analgesics or suppositories in the Post-operative period Intravenous (IV) dexamethasone has been used as an additive to local anesthetic for peripheral nerve blocks (PNBs) in adults with variable efficacy.To the best of our knowledge the efficacy of intravenous dexamethasone as adjuvant to bupivacaine in ultrasound guided axillary brachial plexus block in pediatrics has not been investigated
In this study the investigators will assess the analgesic effect of adding intravenous dexamethasone to bupivacaine in ultrasound guided axillary block in children undergoing upper limb orthopedic surgeries.
Objectives:
- To determine the effect of adding intravenous dexamethasone on the duration of analgesia .
- To determine the effect of adding intravenousdexamethasone on quality of analgesia
详细描述
This a randomized control trial is designed to include (60) patients ASA physical statusI-II patients ranging from(4) to(14)years old scheduled for upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa.
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group A :Axillary block with 2 mg/kg of 0.25% bupivacaine. (n=30) Group B: Axillary block with 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous:(n=30)
All children will be anaesthetized in accordance with the local policy of the Abu El-Reesh pediatric hospital-Cairo university's pediatric anaesthetic unit. Except for oral clear liquids intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, as well as their age and body weight will be recorded. Pre medicated by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg before insertion of intravenous (I.V) cannula.On arriving the operating room, heart rate (HR) ,oxygen saturation and non-invasive blood pressure will be continuously recorded, using standard monitor (Dräger infinity vista XL).
All patients will be induced with propofol 2 mg / kg , atracurium 0.5mg/kg and fentanyl 1μg/kg, then the patients will be intubated 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, with the goal of keeping the BIS measurement between (40-60), and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.Then the block will be conducted after general anesthesia by an expert anesthesiologist who is different from the anesthesiologist who provided anesthesia to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done by computer generated numbers and concealed by serially numbered,opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender both males and females
- •ASA ClassI-II
- •Age 4-14 years
- •Patients under going upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa
排除标准
- •Parent refusal.
- •Patients with apparent infection at site of needle insertion.
- •Patients with any coagulation disorder(Platelets ≤ 50,000 and/or INR> 1.5)
- •Patients with known neuropathy or brachial plexus injury.
- •Patient with known sensitivity to local anesthetic drugs
结局指标
主要结局
Time to first request of opioid analgesia
时间窗: it will be measured in the first 24 hours postoperative
Time to first request of opioid analgesia will be"the time interval between LA injection and the first request to postoperative analgesia (first dose of pethidine adminstration)" (minutes)
次要结局
- Total opioid consumption 24 hours postoperative(It will be measured in the first 24 hours postoperative)
研究者
Ahmed nabih youssef
Lecturer of anesthesia
Kasr El Aini Hospital