Dexamethasone vs dexmedetomidine vs both to prolong popliteal nerve block pain relief in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blinded trial enrolls children aged 3–12 undergoing elective unilateral foot, ankle, or distal lower-leg surgery who will receive a single-shot popliteal sciatic nerve block with 0.2% ropivacaine. Participants are randomly assigned to receive perineural dexamethasone, dexmedetomidine, or the combination added to the local anesthetic, with patients, parents, and pain assessors blinded to group assignment. Trained observers will record pain scores, block duration, time to first rescue analgesia, opioid consumption, and recovery parameters. Follow-up includes telephone checks at 1 week and 1 month to capture pain control and any delayed issues.

Why it matters

Who can join: the full rules

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.

Where it's running

• Poznan University of Medical Sciences
  Poznan, Poland Recruiting

Study contacts

• Study coordinator: Malgorzata Reysner, MD PhD
• Email: mreysner@ump.edu.pl
• Phone: +48 61 873 83 03

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.