💬In plain words
What the trial is, and whether it could suit you
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 p
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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 Criteria:
* 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.
💊
What it tests
- Dexamethasone
- Dexmedetomidine
- Dexamethasone + Dexmedetomidine
Poznan University of Medical Sciences
Poznan, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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