Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children
A Randomized, Double-Blinded, Controlled Trial Comparing Perineural Dexamethasone, Dexmedetomidine, and Their Combination as Adjuvants to Ropivacaine for Popliteal Sciatic Nerve Block in Pediatric Patients
Poznan University of Medical Sciences
120 participants
Jan 16, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
- Child and parents/guardians available for telephone follow-up at 1 week and 1 month after surgery.
Exclusion Criteria11
- 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.
- Local infection, inflammation, or skin lesions at the planned block site.
- Severe cardiac, hepatic, renal, or respiratory disease that, in the investigator's opinion, increases the risk of study participation.
- History of clinically significant arrhythmias, severe bradycardia, or second/third degree atrioventricular block not treated with a pacemaker.
- Developmental delay or severe cognitive impairment that precludes reliable pain assessment or follow-up.
- Chronic use of opioid analgesics or sedatives (≥ 2 weeks of daily use before surgery).
- Participation in another interventional clinical trial within the last 30 days.
- Any other condition considered by the investigator to interfere with protocol adherence, safety monitoring, or reliable outcome assessment.
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Interventions
Perineural 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.
Perineural 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.
Children 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.
Locations(1)
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NCT07289620