Actively Recruiting
A Randomized, Double-Blinded, Controlled Trial Comparing Dexamethasone, Dexmedetomidine, and Their Combination as Additives to Ropivacaine for Popliteal Sciatic Nerve Block in Children
Led by Poznan University of Medical Sciences · Updated on 2026-02-02
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate three commonly used medications added to a local anesthetic during a popliteal sciatic nerve block in children aged 3 to 12 years undergoing surgery on the lower leg or foot. The study compares dexamethasone, dexmedetomidine, and their combination to see if the combination provides longer pain relief and reduces the need for additional pain medication after surgery. It is a randomized, double-blinded, controlled clinical trial focused on improving postoperative comfort in pediatric patients. All children will receive a single injection of 0.2% ropivacaine for the nerve block under ultrasound guidance. Participants will be randomly assigned to one of three groups: ropivacaine with dexamethasone, ropivacaine with dexmedetomidine, or ropivacaine with both dexamethasone and dexmedetomidine. The nerve block will be performed using a 22-gauge echogenic needle under sterile conditions before surgery, and all children will receive standard perioperative pain control. During the study, trained observers who do not know the group assignments will assess pain scores, block duration, opioid use, and recovery. Follow-up calls will occur one week and one month after surgery to check for nerve injury or other effects. The main outcome measured is the time until the first need for additional pain relief within 24 hours after surgery. Secondary measurements include opioid use, behavioral pain scores using FLACC at various times after surgery, adverse events, and early recovery of function.
CONDITIONS
Brief Title
Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 12 years
- Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) under general anesthesia with planned popliteal sciatic nerve block
- ASA physical status I-III
- Parents or legal guardians able to understand 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 will not qualify if you...
- Parents/legal guardians refuse consent or child refuses anesthesia or study procedures
- Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or components of study medications
- Pre-existing neurological deficit or neuromuscular disease affecting lower limbs
- Coagulopathy or therapeutic anticoagulation contraindicating regional anesthesia
- Local infection, inflammation, or skin lesions at nerve block site
- Severe cardiac, liver, kidney, or lung disease increasing participation risk
- History of significant arrhythmias, severe bradycardia, or advanced heart block without pacemaker
- Developmental delay or severe cognitive impairment preventing reliable pain assessment or follow-up
- Chronic opioid or sedative use (2 weeks or more daily before surgery)
- Participation in another interventional trial within last 30 days
- Any condition interfering with protocol adherence, safety monitoring, or outcome assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day at surgery
Participants receive a single-shot popliteal sciatic nerve block with ropivacaine combined with one of the study adjuvants (dexamethasone, dexmedetomidine, or both) prior to surgery. Standard perioperative analgesia is provided to all participants.
1 visit (in-person) for nerve block and surgery
Duration - 1 month postoperatively
Participants are monitored for pain, opioid use, adverse events, and recovery. Pain scores and opioid consumption are assessed over the first 24 hours postoperatively. Additional follow-up includes nerve injury screening at 1 week and 1 month after surgery.
1 to 3 visits including assessments at 24 hours, 1 week, and 1 month after surgery
Trial Site Locations
Total: 1 location
1
Poznan University of Medical Sciences
Poznan, Poland, 62-701
Actively Recruiting
Research Team
M
Malgorzata Reysner, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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