Status:
RECRUITING
Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
Ankle Disease
Foot Diseases
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief 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. ...
Detailed Description
Popliteal sciatic nerve block is frequently used in pediatric anesthesia to provide effective pain control for surgical procedures involving the lower leg, ankle, and foot. Although ropivacaine alone ...
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.
Key Trial Info
Start Date :
January 16 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07289620
Start Date
January 16 2026
End Date
January 31 2027
Last Update
February 2 2026
Active Locations (1)
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1
Poznan University of Medical Sciences
Poznan, Poland, 62-701