[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"quadratus-lumborum-nerve-block\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:quadratus-lumborum-nerve-block":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100623587","comparison-of-caudal-and-quadratus-lumborum-blocks-with-pain-monitoring-in-children-100623587",false,"NCT07398573","Comparison of Caudal and Quadratus Lumborum Blocks With Pain Monitoring in Children","Comparison of the Analgesic Efficacy of Caudal and Quadratus Lumborum Blocks With Pain Monitoring in Lower Abdominal Surgery in Children","Inclusion Criteria:\n\n1. Pediatric patients between 2 months and 6 years of age\n2. Pediatric patients undergoing lower abdominal surgery\n3. Family consent must be obtained\n4. No contraindications to block (infection at the block site), coagulopathy (INR \\\u003C1.4, platelets \\>100,000), local anesthetic allergy)\n5. ASA I-II patients\n\nExclusion Criteria:\n\n1. Severe systemic disease (ASA ≥III)\n2. Infection at the block site\n3. Coagulopathy (INR \\>1.4, platelets \\\u003C100,000)\n4. Local anesthetic allergy\n5. Parental refusal\n6. Children aged \\\u003C2 months or \\>6 years","ALL","2 Months","6 Years",{"count":20,"type":21},68,"ESTIMATED","OBSERVATIONAL","Study Type: Prospective, Randomized, Observational Clinical Study\n\nPrimary Purpose:\n\nThe 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.\n\nKey Questions Addressed:\n\nDoes 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?\n\nIs the PAM monitor a reliable tool for objectively assessing nociception and pain in children who are unable to verbally express pain?\n\nWhich regional anesthesia technique more effectively delays the time to first postoperative analgesic requirement and reduces total analgesic consumption?\n\nWhich method is associated with higher parental satisfaction and fewer postoperative side effects, such as postoperative nausea and vomiting?\n\nComparison Groups:\n\nChildren receiving ultrasound-guided quadratus lumborum block will be compared with those receiving caudal block.\n\nIntervention Group:\n\nBilateral quadratus lumborum block with 0.5 mL\u002Fkg of 0.25% bupivacaine.\n\nActive Comparator Group:\n\nCaudal block with 1 mL\u002Fkg of 0.125% bupivacaine.\n\nParticipant Population:\n\nA 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).\n\nWhat Participants Will Do:\n\nParticipants will receive the assigned regional block as part of standard anesthetic care. Observational data will be collected as follows:\n\nIntraoperative: 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).\n\nPostoperative: Pain assessment using the FLACC scale at 1, 2, and 4 hours in the post-anesthesia care unit.\n\nRescue analgesia (intravenous paracetamol) will be administered if the FLACC score is ≥4. Time to first analgesic administration and total analgesic consumption will be recorded.\n\nAdditional outcomes include postoperative nausea and vomiting (PONV) scores, Steward recovery scores, and parental satisfaction scores assessed using the Pediatric Parental Satisfaction Scale (PPPS).\n\nPrimary Outcome:\n\nIntraoperative PAM index scores.\n\nSecondary Outcomes:\n\nPostoperative FLACC scores, time to first analgesic requirement, total postoperative analgesic consumption, incidence and severity of PONV, Steward recovery scores, and parental satisfaction (PPPS) scores.",[25,26,27,28,29],"Regional Anesthesia Success","Pain Monitor During Anesthesia","Quadratus Lumborum Nerve Block","Caudal Block for Postoperative Analgesia","Pediatric Anesthesia",[29,31,32],"Regional Block","Pain Monitoring","NOT_YET_RECRUITING","2026-02-02",{"date":36,"type":37},"2026-02-10","ACTUAL",{"date":34,"type":21},{"date":40,"type":21},"2026-04-30",{"name":42,"class":43},"Ankara Etlik City Hospital","OTHER_GOV"]