Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT07289620
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT07289620
Study Brief:
Protocol Section:
NCT07289620