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.
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)
Severe systemic disease (ASA ≥III)
Infection at the block site
Coagulopathy (INR >1.4, platelets <100,000)
Local anesthetic allergy
Children aged 2 months to 6 years with ASA I-II status undergoing lower abdominal surgeries (e.g., inguinal hernia, orchiopexy, hydrocele) performed by the pediatric surgery unit at Etlik City Hospital will be included.
Cohort
Prospective
Not listed
Intraoperative Pain Index Scores Measured by MEDSTORM Pain Monitor (PAM)
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
Postoperative Pain Intensity Measured by FLACC Scale
Postoperative pain intensity will be assessed using the FLACC behavioral pain scale in children undergoing lower abdominal surgery who receive either a Caudal Block or a Quadratus Lumborum (QL) Block. The FLACC scale evaluates five behavioral categories: Face, Legs, Activity, Cry, and Consolability. Each category is scored from 0 to 2, resulting in a total score ranging from 0 to 10, where higher scores indicate greater pain intensity.
Time to First Postoperative Analgesic Requirement
Outcome Measure Description The duration of postoperative analgesia will be assessed by recording the time from the end of surgery to the first requirement for rescue analgesia. The need for rescue analgesia will be determined based on postoperative pain assessment using the FLACC behavioral pain scale. A FLACC score ≥4 will be used as the predefined threshold for rescue analgesic administration. Unit of Measure Hours
Number of Participants Requiring Postoperative Rescue Analgesia
Outcome Measure Description The requirement for postoperative rescue analgesia will be recorded based on FLACC pain scores assessed at predefined postoperative time points. Participants with a FLACC score ≥4 will be considered as requiring rescue analgesia according to the institutional postoperative analgesia protocol. Unit of Measure Number of participants
Total Postoperative Paracetamol Dose Administered
Total postoperative rescue analgesic consumption will be recorded. Rescue analgesia will be administered intravenously as paracetamol at a dose of 15 mg/kg when the FLACC score is ≥4. The cumulative paracetamol dose administered during the postoperative observation period will be calculated for each participant. Unit of Measure mg/kg
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