Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Adult Patients Undergoing Lumbosacral Spine Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- postoperative analgesia
研究概览
简要总结
It is widely believed that major lumbosacral spine surgeries are associated with severe postoperative pain that may delay the functional recovery of the patient. Caudal epidural injection (CE) has an important role in providing effective pain relief post lumbosacral spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) is a relatively new technique of trunk fascial block which was introduced in 2016. Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics.The overall benefit of intravenous (IV) analgesia versus pre-emptive analgesia by caudal epidural or erector spinae block is still controversial.
The aim of this study is to compare the pre-emptive analgesic effect of bilateral erector spinae plane block versus Caudal epidural analgesia versus the conventional intravenous analgesia in adult patients undergoing lumbosacral spine surgeries under general anesthesia.
详细描述
78 Participants undergoing lumbosacral spine surgeries who met the inclusion criteria will be divided into three groups each group contains 26 patients:
Group (CE): Patients receiving caudal epidural block. Group (ESP): Patients receiving bilateral erector spinae plane block. Group (C): Control group, patients receiving general anesthesia with intravenous analgesia.
• Study procedures:
- Routine preoperative assessment will be done for all the participants.
- All participants will be fasting before the procedure not less than 6 hours.
- General anesthesia will be induced with midazolam (0.05mg/kg), propofol (1.5-2mg/kg), fentanyl (1-2μg/kg) and atracurium (0.5mg/kg),
- Tracheal intubation will be performed. After induction, general anesthesia will be maintained with a volatile anesthetic agent (0.9:1.2% isoflurane) and controlled ventilation with atracurium every 20 mins (0.1 mg/kg).
- Standard monitoring of mean arterial blood pressure (MAP), heart rate (HR) and peripheral pulse oximeter (SPO2) value will be monitored at time of induction (time 0) and every 10 minutes till the end of the procedure.
Group (CE): Caudal epidural group The patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound guidance using SonoSite M Turbo(USA).The scanning probe is the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13 megahertz linear array)that is covered in sterile plastic bag.Short axis (transverse view) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal view) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.25% bupivacaine will expand the epidural space.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for lumbosacral spine surgery level from L4 to S
- •American Society of Anesthesiologists classification (ASA) class I or II.
排除标准
- •Refusal of procedure or participation in the study.
- •American Society of Anesthesiologists classification (ASA) class III or IV.
- •Coagulation disorders (platelets count < 100,000; International normalized ratio >1.4; Patient control time< 60%) and coagulopathies.
- •Skin lesion or infection at the injection site.
- •Known allergy to any of the medications used.
- •Chronic opioid users.
- •Patients with pre-operative opioid consumption
结局指标
主要结局
postoperative analgesia
时间窗: 24 hours postoperative
using the visual analogue scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
次要结局
- intraoperative mean arterial blood pressure(every 10 minutes intraoperative till end of surgery)
- intraoperative heart rate(every 10 minutes intraoperative till end of surgery)
- Number of participant with postoperative vomiting(during the 24 hours postoperative)
- Number of participant with postoperative nausea(during the 24 hours postoperative)
- Number of participant with postoperative urinary retention(during the 24 hours postoperative)
- postoperative first rescue analgesia time(during the 24 hours postoperative)
- Surgical field bleeding.(from the start till the end of the operation)
研究者
RAMY AHMED
Assistant Professor of Anesthesia
Ain Shams University