Comparison of Erector Spinae Plane block versus Caudal block for Postoperative analgesia in children undergoing Developmental Dysplasia of Hip Surgery - A Prospective Randomized Control Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Mean FLACC scale at 15min,30mins,40mins,60mins,2hrs,6hrs,12hrs,24hrs.
概览
简要总结
This trial is a prospective randomized controlled study comparing the effectiveness of Erector Spinae Plane Block (ESPB) versus Caudal Block (CB) for postoperative pain management in children undergoing Developmental Dysplasia of Hip (DDH) surgery. The primary goal is to assess which of these two ultrasound-guided regional anesthetic techniques provides superior postoperative analgesia.
Developmental Dysplasia of Hip surgery can cause significant pain in children, making effective pain control essential for recovery and to minimize opioid use. The Caudal Block, while a conventional method, has potential risks and limited duration. The Erector Spinae Plane Block is a newer, less invasive technique that may offer a safer and longer-lasting alternative, but its efficacy in pediatric hip surgery needs further investigation.
The study will include 44 pediatric patients, aged 1 to 7 years, classified as ASA I-II, who are undergoing elective DDH surgery at the All India Institute of Medical Sciences, Vijaypur, Jammu. Patients will be randomly assigned into two equal groups: one receiving an Ultrasound Guided Caudal Block and the other an Ultrasound Guided Erector Spinae Plane Block. Randomization will be computer-generated to ensure unbiased group assignment, and assignments will be blinded to researchers and statisticians.
Before surgery, patients will receive premedication. General Anesthesia will be administered, and both regional blocks will be performed under ultrasound guidance. The ESPB will be administered at the L2-L3 level, and the CB at the sacral hiatus, with 0.5 ml/kg of 0.25% bupivacaine injected in both cases.
The primary outcome measure will be postoperative analgesia, assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) pain scale at multiple time points (0, 15, 30, 45, 60 minutes, 2, 6, 12, and 24 hours) after surgery. All patients will receive routine paracetamol. Rescue analgesia (Syrup Ibuprofen) will be given if the FLACC score is 4 or higher, and the time to the first rescue analgesia will be recorded.
Secondary outcomes include the mean time to first rescue analgesia, the total number of rescue analgesic doses consumed within 24 hours, parental satisfaction with pain relief, the number of attempts to successfully perform the block, and the incidence of block-related complications such as nausea, vomiting, hematoma, or urinary retention.
The study is designed with ethical considerations, including approval from the Institutional Ethics Committee and obtaining informed consent from parents or guardians. Patient confidentiality will be maintained, and participants can withdraw from the study at any time without affecting their medical care. The trial is scheduled from January 2026 to November 2026, followed by data analysis and dissemination of results. This research aims to identify the optimal regional anesthetic technique for postoperative pain management in this specific pediatric surgical population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 1.00 Year(s) 至 7.00 Year(s)(—)
- 性别
- All
入选标准
- •Paediatric patient of ASA I-II
- •7yrs of age either sex undergoing developmental dysplasia of hip surgery.
排除标准
- •Parent or guardian refusal to participate.
- •Infection at the local site of injection.
结局指标
主要结局
Mean FLACC scale at 15min,30mins,40mins,60mins,2hrs,6hrs,12hrs,24hrs.
时间窗: Mean FLACC scale at 15min,30mins,40mins,60mins,2hrs,6hrs,12hrs,24hrs.
次要结局
- The mean time for requirement of first rescue analgesia as determined by FLACC(At the end)
研究者
Dr Ajay Shanakr S
Department of Anaesthesiology All India Institute of Medical Sciences ,Jammu