Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery; a Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- pain score with FLACC
研究概览
简要总结
Children can experience substantial pain after hip operations, causing agitation, depression, and sleep disruption, which can have a negative impact on their health. Opioids are associated with several serious side effects that limits its use as solo agents for pain management. Regional blocks such as caudal Block (CB) and pericapsular nerve group (PENG) block in adjuvant with general anaesthesia are alternative perioperative analgesic techniques that lead to lesser side effects, including motor weakness, postoperative nausea and vomiting with decreased opioid consumption.
详细描述
Regional anesthesia is often used to prevent postoperative pain in pediatric surgery. Combined with general anesthesia (GA), ultrasound (US)-guided regional anesthetic approaches provide simple intraoperative pathway that reduced GA requirements, lower pain score with less impact on the respiratory or cardiovascular system
In pediatric surgery, caudal block (CB) is a low-cost, simple, and effective procedure for postoperative analgesia. CB is suggested for most surgeries in the lower body, primarily below the umbilicus. Although the well-established anesthetic properties of CB, its action terminates early in the postoperative period and it has a number of restrictions, such as anatomical abnormalities or infection at the injection site, that can prevent its use
PENG block is the plane lying between the psoas muscle and tendon and the ilio-pubic eminence. The single-shot PENG block has lately been reported in the cadaveric study and in the literature for perioperative pain management in hip surgery by aiming the articular arms of the accessory obturator nerve (AON), femoral nerve (FN), and obturator nerve (ON). The technical simplicity of imaging in traction-fixed patients and no need for multiple punctures made this blockage ideal for young pediatric patients. Unfortunately, there are no adequate studies regarding PENG block in patients younger than five years old.
This study was carried out to assess ultrasound-guided PENG block versus CB for their efficacy, safety and pain management in pediatric hip surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child aged 1- 7 years old
- •American Society of Anesthesiologists (ASA) physical status I-II
- •scheduled for elective hip surgery under general anesthesia
排除标准
- •parents/guardians refusal to participate
- •known local anesthetic drug sensitivity,
- •bleeding disorders,
- •pre-existing infection at the block site, and
- •the presence of major cardiac, renal, or hepatic disorders.
结局指标
主要结局
pain score with FLACC
时间窗: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative
(Face, Legs, Activity, Cry, and Consolability scale to assess pain in young children. Each category is scored on a 0-2 scale which results in a total score between 0 (lowest pain) and 10 (worst pain).
次要结局
- The duration of the block(immediately after the intervention, up to 24 hours postoperative)
- the Time to first postoperative rescue analgesia(24 hours postoperative)
- Total rescue analgesia consumption(24 hours postoperative)
- The incidence of postoperative adverse effects(24 hours postoperative)
- Parents satisfaction score(24 hours postoperative)
- The duration of the block(immediately after the intervention, up to 24 hours postoperative)
- the Time to first postoperative rescue analgesia(24 hours postoperative)
- Total rescue analgesia consumption(24 hours postoperative)
- The incidence of postoperative adverse effects(24 hours postoperative)
- Parents satisfaction score(24 hours postoperative)
研究者
Samar Rafik Mohamed Amin
Assistant professor of anaesthesia and intensive care
Benha University