Dexmedetomidine Vs Dexamethasone in Popliteal Nerve Block
NCT ID: NCT06304324
Last Updated: 2025-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2024-05-06
2025-04-30
Brief Summary
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Detailed Description
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After ankle/foot surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.
The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sham Block
0.2% ropivacaine for popliteal nerve block
0.9% Sodium chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
Dexamethasone
0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block
0.1mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
Dexmedetomidine
0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block
0.05ug/kg Dexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block
Interventions
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0.9% Sodium chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
0.1mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
0.05ug/kg Dexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* body weight \> 5kg
Exclusion Criteria
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
3 Months
18 Years
ALL
No
Sponsors
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Poznan University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Tomasz Kotwicki, Prof dr hab
Role: STUDY_CHAIR
Poznan University of Medical Sciences
Locations
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Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, Poland
Countries
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Central Contacts
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Malgorzata Domalska, PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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18/2023
Identifier Type: -
Identifier Source: org_study_id
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