NCT07289620 Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children
| NCT ID | NCT07289620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poznan University of Medical Sciences |
| Condition | Ankle Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-01-16 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 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.
Contact & Investigator
MAlgorzata Reysenr, MD PhD
STUDY CHAIR
Poznań University of Medicla Sciences
Frequently Asked Questions
Who can join the NCT07289620 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Ankle Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07289620 currently recruiting?
Yes, NCT07289620 is actively recruiting participants. Contact the research team at mreysner@ump.edu.pl for enrollment information.
Where is the NCT07289620 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT07289620 clinical trial?
NCT07289620 is sponsored by Poznan University of Medical Sciences. The principal investigator is MAlgorzata Reysenr, MD PhD at Poznań University of Medicla Sciences. The trial plans to enroll 120 participants.