Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
NCT ID: NCT06086418
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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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2023-10-17
2024-03-30
Brief Summary
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Detailed Description
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After foot and ankle 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 anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics 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 different doses of perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.
The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously 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
TRIPLE
Study Groups
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placebo
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
0.1mg/kg 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
0,05mg/kg dexamethasone
0.05mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block
0.05mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone 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
0.05mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone 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_DIRECTOR
Poznan University of Medical Sciences
Locations
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Poznan University of Medical Sciences
Poznan, Poznań, Poland
Countries
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References
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Reysner M, Reysner T, Janusz P, Kowalski G, Shadi M, Daroszewski P, Wieczorowska-Tobis K, Kotwicki T. Dexamethasone as a perineural adjuvant to a ropivacaine popliteal sciatic nerve block for pediatric foot surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2024 Aug 29:rapm-2024-105694. doi: 10.1136/rapm-2024-105694. Online ahead of print.
Other Identifiers
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13/2023
Identifier Type: -
Identifier Source: org_study_id
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