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Compares treatment options for Ankle Disease
Official title Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children
ClinicalTrials.gov ID: NCT07289620
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, being studied as a potential treatment for ankle disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Poznan, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poznan, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.