Dexamethasone vs dexmedetomidine vs both to prolong popliteal nerve block pain relief in children
A Randomized, Double-Blinded, Controlled Trial Comparing Perineural Dexamethasone, Dexmedetomidine, and Their Combination as Adjuvants to Ropivacaine for Popliteal Sciatic Nerve Block in Pediatric Patients
This trial will test whether adding dexamethasone, dexmedetomidine, or both to a popliteal nerve block gives children having lower-leg or foot surgery longer pain relief and reduces the need for extra pain medicine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan) |
| Trial ID | NCT07289620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 3 to 12 years scheduled for elective unilateral lower-limb (foot, ankle, or distal lower leg) surgery with a planned popliteal sciatic nerve block, ASA I–III, whose parents/guardians can provide consent and participate in follow-up.
Not a fit: Children with known allergy to the study drugs, pre-existing lower-limb neurologic or neuromuscular disease, coagulopathy or anticoagulation, local infection at the block site, those outside the age range, or unable/unwilling to complete follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the combination could provide longer-lasting pain relief after surgery, reduce opioid requirements, and improve postoperative comfort for children.
How similar studies have performed: Prior adult and pediatric work shows that dexamethasone and dexmedetomidine individually prolong peripheral nerve block duration, but evidence on their combined perineural use is limited and mixed, especially in children.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Poznan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.