This clinical study will evaluate three commonly used medications that can be added to local anesthetic during a popliteal sciatic nerve block in children undergoing surgery of the lower leg or foot. These medications-dexamethasone, dexmedetomidine, or a combination of both-may help the nerve block last longer and provide better postoperative pain control.
All participating children will receive a standard popliteal sciatic nerve block with ropivacaine, a commonly used local anesthetic. They will then be randomly assigned to one of three groups: (1) ropivacaine with dexamethasone, (2) ropivacaine with dexmedetomidine, or (3) ropivacaine with both dexamethasone and dexmedetomidine. Neither the children, parents, nor the clinical staff assessing pain will know which medication was given.
The goal of this study is to determine whether the combination of dexamethasone and dexmedetomidine provides longer pain relief and reduces the need for additional pain medication compared with either medication alone. The results may help identify the most effective and safest strategy for improving postoperative comfort in pediatric patients receiving regional anesthesia.
Children aged 3 to 12 years.
Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) under general anesthesia with a popliteal sciatic nerve block planned for postoperative analgesia.
ASA physical status I-III.
Ability of parents or legal guardians to understand the study procedures and provide written informed consent.
Refusal of the parents/legal guardians to provide informed consent or refusal of the child to cooperate with anesthesia or study procedures.
Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any component of the study medications.
Pre-existing neurological deficit or neuromuscular disease affecting the lower limbs (motor or sensory).
Coagulopathy or current therapeutic anticoagulation that contraindicates regional anesthesia.
Parallel
Dexamethasone
DrugPerineural dexamethasone will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone, injected under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. The medication will be given as a single perineural dose only. Standard perioperative analgesia will be provided to all participants.
Dexmedetomidine
DrugPerineural dexmedetomidine will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg dexmedetomidine, injected under ultrasound guidance with a 22-gauge echogenic needle prior to surgery. The medication will be administered as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.
Dexamethasone + Dexmedetomidine
DrugChildren in this arm will receive a combination of two perineural adjuvants added to a single-shot popliteal sciatic nerve block. The block will include 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone and 0.5 µg/kg dexmedetomidine, administered under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. Both medications will be delivered together as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.
Time to First Rescue Analgesia
Time in hours from completion of the popliteal sciatic nerve block to the first administration of rescue analgesic medication. Rescue analgesia will be provided when the FLACC pain score is ≥ 4, or upon patient/parent request. This measure reflects the duration of effective postoperative analgesia provided by the nerve block.
Total Opioid Consumption
Total amount of opioid rescue medication administered within the first 24 hours after surgery, converted to morphine milligram equivalents (MME). Includes all postoperative rescue doses documented in the anesthesia and nursing records.
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
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