Comparison of analgesic efficacy of ultrasound-guided transversus abdominis plane block and erector spinae plane block in children undergoing unilateral open inguinal hernia repair under general anaesthesia; a single-centre, prospective, parallel-group, randomized comparative study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Comparison of postoperative pain, documented as Face, Legs, Activity, Cry, Consolability (FLACC) scale after ESPB and TAPB in pediatric patients undergoing unilateral open inguinal hernia surgery under GA.
研究概览
简要总结
Open inguinal hernia repair is one of the common surgical treatments, particularly in pediatric patients. Due to the potential for considerable postoperative pain, especially in the early recovery period because of extensive dissection and manipulation of muscles (Internal Oblique and Transversus abdominis) and fascial layers, achieving appropriate analgesia is crucial after such surgeries. Severe post operative pain might occur after hernia surgery due to entrapment of nerves like ilioinguinal, iliohypogastric as well as genital branch of genitofemoral nerve. In addition, inflammatory response after surgery can lead to delayed recovery, impaired wound healing, increased stress response, increased risk of infections, deep vein thrombosis and reduced parental satisfaction.
The quest for effective, safe, and opioid-sparing analgesia in paediatric anaesthesia has led to the exploration of newer regional blocks. In recent years, TAPB and ESPB have emerged as reliable alternatives for postoperative pain management in lower abdominal surgeries, including inguinal hernia repairs. However, choosing appropriate block still remains a challenge. There is various evidence available against both of these blocks.
Primary objectives includecomparison of postoperative pain, documented as Face, Legs, Activity, Cry, Consolability (FLACC) scale after ESPB and TAPB in pediatric patients undergoing unilateral open inguinal hernia surgery under GA.
Secondary objectives being comparison of intraoperative opioid requirement after surgical incision, comparison of time to first rescue analgesia required, comparison of total parenteral analgesic consumption, assessment of the impact of ESPB and TAPB on postoperative nausea and vomiting (PONV), length of hospital stays and parental satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Paediatric patients aged one to eight years, undergoing open unilateral inguinal hernia repair under GA.
- •American Society of Anesthesiologists (ASA) performance status 1 and 2 patients.
排除标准
- •Refusal to participate in the study.
- •Patients with coagulopathy, local infection or hematoma in the block target area.
- •Patients with allergy to local anesthetic (LA) agents or any of the drugs used in the study.
结局指标
主要结局
Comparison of postoperative pain, documented as Face, Legs, Activity, Cry, Consolability (FLACC) scale after ESPB and TAPB in pediatric patients undergoing unilateral open inguinal hernia surgery under GA.
时间窗: Baseline
次要结局
- - Comparison of intraoperative opioid requirement after surgical incision in pediatric patients undergoing unilateral open inguinal hernia surgery who received ESPB & TAPB.(- Comparison of time to first rescue analgesia required in children undergoing unilateral open inguinal hernia surgery who received ESPB & TAPB.)