Ultrasonically Versus Conventional Palpation for Epidural Analgesia in Pediatrics Undergoing Midabdominal Urological Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- the rate of a successful reaching to the epidural space from the first needle pass
研究概览
简要总结
Epidural analgesia for abdominal surgeries provides numerous advantages for both neonates and children. The anatomical identification of the intervertebral space to access the epidural space is not constantly easy this is due uncertainty of the direction of the needle angle and the difficulty to estimate the epidural depth in spite of the skill of the operator. This can lead to more puncture attempts, inducing more pain or discomfort and even failure of epidural access.
Pre-procedure neuraxial ultrasound (US) imaging facilities the identification of the chosen intervertebral space, the depth of the epidural space and so the selection of best point and angle for the needle insertion
详细描述
The aim of this study is to evaluate the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique
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
- Double (Participant, Investigator)
盲法说明
Patients will be randomly assigned to 2 equal groups (ultrasonography and palpation; 55 subjects in each group) using the permuted block randomization method with randomly selected block sizes of 4 and 6. The group allocation codes were concealed in sequentially numbered, opaque, sealed envelopes that were opened only after assessing the eligibility and obtaining the consent from the parents
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged from 1 to 12 years old
- •Both genders
- •American Society of Anesthesiologists (ASA) physical status I,II, III
- •Scheduled for open midabdominal urological surgeries under general anesthesia
排除标准
- •Pediatric patients aged less than 1 or more than 12 years old
- •American Society of Anesthesiologists (ASA) physical status Iv
- •Parents' refusal to participate in the study
- •Any contraindication to epidural block (as severe infection at the puncture site, coagulopathy or hemodynamically unstable patients)
- •Neuromuscular diseases
- •Severe spinal deformity
- •History of allergy to the anesthetic drugs
研究组 & 干预措施
palpation group
In lateral decubitus position, the conventional palpation technique will be used to detect the epidural space. The midline will be identified by palpation of the spinous processes. Through the Tuffier's line, L5 spine then, the two intervertebral spaces (L3-4 and L2-3) will be detected and the middle of each intervertebral space will be marked with selection of the widest space.
After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline
Ultrasonography group
In lateral decubitus position, a curved array probe will be utilized to scan the sacrum in the longitudinal paramedian plane, then the probe will be moved upwards to detect the L5-S1, L4-5, L3-4 and L2-3 intervertebral spaces then turned 90º to the transverse plane and used to scan L3-4 and L2-3 spaces inside the 2 spaces, midline will be detected by noting the site of spinous processes with selection of the space with the best sonographic image quality. Then skin surface at the middle of the long and short axis of the probe will be marked horizontally. If the 2 spaces have the same image quality, L2-3 space will be chosen for the entrance of epidural needle. After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline
干预措施: ultrasound (Device)
结局指标
主要结局
the rate of a successful reaching to the epidural space from the first needle pass
时间窗: minutes
incidence after insertion of the epidural needle into the skin till reaching the epidural space
次要结局
- the rate of a successful reaching to the epidural space from the first skin puncture(minutes)
- The epidural space demarcation time by the ultrasound(minutes)
- The epidural space demarcation time by the landmark(minutes)
- The number of performed skin punctures by the epidural needle(minutes)
- The procedure time(minutes)
- Incidence of intraoperative tachycardia (as increase in heart rate by more than 20% from the basal)(allover the surgery (minutes))
- The number of needle passes from the same skin puncture required for reaching the epidural space(minutes)
- The procedure time which is the time from the needle insertion into the skin until reaching the epidural space(minutes)
- Incidence of intraoperative hypertension (as increase in systolic blood pressure (SBP) by more than 20% from the basal)(allover the surgery (minutes))
- pain score using "face, leg, activity, cry, consolability" (FLACC) scale(30 minutes after the patient has transferred to the recovery room)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University