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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
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• 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.
Locations
Other Locations
Poland
Poznan University of Medical Sciences
RECRUITING
Poznan
Contact Information
Primary
Malgorzata Reysner, MD PhD
mreysner@ump.edu.pl
+48 61 873 83 03
Time Frame
Start Date:2026-01-16
Estimated Completion Date:2027-01-31
Participants
Target number of participants:120
Treatments
Active_comparator: Perineural Dexamethasone
Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone (maximum dose per institutional pediatric guidelines). The block will be performed using a 22-gauge echogenic needle under sterile conditions prior to the start of surgery. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants.
Active_comparator: Perineural Dexmedetomidine
Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg perineural dexmedetomidine (maximum dose per institutional pediatric guidelines). A 22-gauge echogenic needle will be used for block placement under sterile conditions. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants.
Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone and 0.5 µg/kg perineural dexmedetomidine (maximum doses per institutional pediatric guidelines). The block will be performed with a 22-gauge echogenic needle under sterile conditions before surgery. Standard perioperative analgesia will be provided to all participants.