About this trial
This prospective, randomized, controlled trial aims to evaluate the postoperative analgesic efficacy of combined ultrasound-guided popliteal sciatic nerve block and adductor canal block in children with cerebral palsy undergoing elective lower extremity surgery. Children aged 3-18 years with American Society of Anesthesiologists (ASA) physical status II-III will be randomized into two groups. Participants in the intervention group will receive combined popliteal sciatic nerve block and adductor canal block in addition to general anesthesia, whereas participants in the control group will receive general anesthesia with intravenous analgesia without peripheral nerve block. Postoperative pain will be assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) scale at 1, 2, 6, 12, and 24 hours after surgery by an anesthesiologist blinded to group allocation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients aged 3-18 years
Diagnosis of cerebral palsy
Scheduled to undergo lower extremity surgery
American Society of Anesthesiologists (ASA) physical status II-III
Disqualifiers
Age younger than 3 years or older than 18 years
Coagulopathy or any contraindication to peripheral nerve block
Known allergy to local anesthetics
Infection at the planned block site
Trial design
Parallel
Treatments tested in this trial
Adductor Canal Block + Popliteal Sciatic Nerve Block Group
Procedure/SurgeryFollowing induction of general anesthesia, participants assigned to the intervention group will receive ultrasound-guided popliteal sciatic nerve block and adductor canal block. Both blocks will be performed using 0.25% bupivacaine, with a total local anesthetic volume of 0.5 mL/kg for the combined blocks (maximum volume 20 ml).
Control Group
Procedure/SurgeryParticipants assigned to the control group will receive intravenous paracetamol at a dose of 15 mg/kg intraoperatively as part of the standard analgesic protocol. No peripheral nerve block will be performed in this group.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain intensity assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) scale
Postoperative pain intensity will be assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) observational pain scale. The r-FLACC score ranges from 0 to 10, with higher scores indicating greater pain intensity. r-FLACC scores will be recorded at 1, 2, 6, 12, and 24 hours after surgery and compared between the two study groups.
Secondary outcomes
Total rescue analgesic consumption during the first 24 postoperative hours
The cumulative dose and number of doses of each rescue analgesic administered during the first 24 hours after surgery will be recorded separately. When the r-FLACC score is ≥4, intravenous morphine 25 µg/kg will be administered in the post-anesthesia care unit, whereas oral ibuprofen 10 mg/kg will be administered in the inpatient ward.
Intraoperative remifentanyl consumption
The cumulative dose of remifentanyl administered during the intraoperative period.
Sponsors and contacts
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Diskapi Yildirim Beyazit Education and Research Hospital
Lead sponsor
Ankara Etlik City Hospital
Sponsor institution
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