Comparison of the Analgesic Efficacy of Caudal and Quadratus Lumborum Blocks With Pain Monitoring in Lower Abdominal Surgery in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Intraoperative Pain Index Scores Measured by MEDSTORM Pain Monitor (PAM)
研究概览
简要总结
Study Type: Prospective, Randomized, Observational Clinical Study
Primary Purpose:
The primary objective of this study is to compare the analgesic efficacy of caudal block (CB) and quadratus lumborum block (QLB) in children undergoing lower abdominal surgery using objective pain monitoring methods.
Key Questions Addressed:
Does the quadratus lumborum block provide superior intraoperative and postoperative analgesia compared to the caudal block, as measured by the Pain Monitor (PAM) and the FLACC scale?
Is the PAM monitor a reliable tool for objectively assessing nociception and pain in children who are unable to verbally express pain?
Which regional anesthesia technique more effectively delays the time to first postoperative analgesic requirement and reduces total analgesic consumption?
Which method is associated with higher parental satisfaction and fewer postoperative side effects, such as postoperative nausea and vomiting?
Comparison Groups:
Children receiving ultrasound-guided quadratus lumborum block will be compared with those receiving caudal block.
Intervention Group:
Bilateral quadratus lumborum block with 0.5 mL/kg of 0.25% bupivacaine.
Active Comparator Group:
Caudal block with 1 mL/kg of 0.125% bupivacaine.
Participant Population:
A total of 68 children, aged 2 months to 6 years, with ASA physical status I-II, scheduled for elective lower abdominal surgeries (e.g., inguinal hernia repair, orchiopexy, hydrocele).
What Participants Will Do:
Participants will receive the assigned regional block as part of standard anesthetic care. Observational data will be collected as follows:
Intraoperative: Continuous nociception monitoring using the PAM device at predefined time points (during laryngeal mask airway insertion, block performance, surgical incision, 20 minutes after block performance, and extubation).
Postoperative: Pain assessment using the FLACC scale at 1, 2, and 4 hours in the post-anesthesia care unit.
Rescue analgesia (intravenous paracetamol) will be administered if the FLACC score is ≥4. Time to first analgesic administration and total analgesic consumption will be recorded.
Additional outcomes include postoperative nausea and vomiting (PONV) scores, Steward recovery scores, and parental satisfaction scores assessed using the Pediatric Parental Satisfaction Scale (PPPS).
Primary Outcome:
Intraoperative PAM index scores.
Secondary Outcomes:
Postoperative FLACC scores, time to first analgesic requirement, total postoperative analgesic consumption, incidence and severity of PONV, Steward recovery scores, and parental satisfaction (PPPS) scores.
详细描述
Study Title:
Comparison of the Analgesic Efficacy of Caudal and Quadratus Lumborum Blocks Using a Pain Monitor in Children Undergoing Lower Abdominal Surgery
Study Objectives
Primary Objective:
To compare the analgesic efficacy of caudal block and quadratus lumborum block (QLB) using an objective pain monitoring device (Pain Monitor; PAM).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients between 2 months and 6 years of age
- •Pediatric patients undergoing lower abdominal surgery
- •Family consent must be obtained
- •No contraindications to block (infection at the block site), coagulopathy (INR <1.4, platelets >100,000), local anesthetic allergy)
- •ASA I-II patients
排除标准
- •Severe systemic disease (ASA ≥III)
- •Infection at the block site
- •Coagulopathy (INR >1.4, platelets <100,000)
- •Local anesthetic allergy
- •Parental refusal
- •Children aged <2 months or >6 years
研究组 & 干预措施
CAUDAL BLOCK GROUP
Under ultrasound guidance, a caudal block with 1 ml/kg of 0.125% bupivacaine (maximum volume 20 ml) will be performed.
QUADRATUS LUMBORUM BLOCK GROUP
Intraoperatively, under ultrasound guidance, bilateral QL block with 0.5 ml/kg of 0.25% bupivacaine (maximum volume 20 ml) will be performed.
结局指标
主要结局
Intraoperative Pain Index Scores Measured by MEDSTORM Pain Monitor (PAM)
时间窗: Perioperative period, at the following predefined time points: At airway instrumentation (laryngeal mask airway insertion) During regional block performance At skin incision 20 minutes after block performance At emergence from anesthesia (extubation)
The intraoperative analgesic efficacy of Caudal Block and Quadratus Lumborum (QL) Block will be assessed using the MEDSTORM Pain Monitor (PAM). The PAM provides a Pain Index score ranging from 0 to 10, reflecting the patient's nociceptive state and the need for analgesic intervention. Lower scores indicate better analgesic efficacy. Pain Index scores will be recorded at predefined perioperative time points. It is hypothesized that the QL block will result in lower intraoperative Pain Index scores compared to the caudal block. Pain Index interpretation: 0-1: No additional analgesia required 2-3: Additional analgesia may be required 4-5: Additional analgesia is likely required 6-7: Additional analgesia is probably needed 8-10: Additional analgesia is required Perioperative period, at the following predefined time points: At airway instrumentation During regional block performance At skin incision 20 minutes after block performance At emergence from anesthesia
次要结局
- Postoperative Pain Intensity Measured by FLACC Scale(Postoperative period, assessed at: 1 hour after surgery 2 hours after surgery 4 hours after surgery)
- Time to First Postoperative Analgesic Requirement(Postoperative period, up to 4 hours after surgery)
- Number of Participants Requiring Postoperative Rescue Analgesia(Postoperative period, assessed at: 1 hour 2 hours 4 hours after surgery)
- Total Postoperative Paracetamol Dose Administered(Time Frame Postoperative period, up to 4 hours after surgery)
- Adverse Effects, Postoperative Nausea and Vomiting (PONV) Severity Score(Postoperative period, assessed at: 1 hour 2 hours 4 hours after surgery)
- Postoperative Parental Satisfaction Score Assessed by the Pediatric Parental Satisfaction Scale (PPPS)(Postoperative period, assessed at: 1 hour 2 hours 4 hours after surgery)
- Postoperative Recovery Score Assessed by the Steward Score(Postoperative period, assessed at: 1 hour 2 hours 4 hours after surgery)
研究者
DILARA YIGIT
Sub-Investigator
Ankara Etlik City Hospital