Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
NCT ID: NCT05887778
Last Updated: 2023-10-13
Study Results
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Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2023-09-18
2024-08-01
Brief Summary
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Detailed Description
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After hand and wrist 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 systemic Dexamethasone. Before the anesthesia, the patients receive Dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.2mg/kg.
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 injection
5ml of 0,9% sodium chloride - before the popliteal nerve block
Sodium Chloride 0.9% Inj
administration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block
0,1mg/kg Dexamethasone
0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
0,1mg/kg Dexamethasone
administration of 0,1mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block
0,2 mg/kg Dexamethasone
0,2 mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
0,2mg/kg Dexamethasone
administration of 0,2mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block
Interventions
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Sodium Chloride 0.9% Inj
administration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block
0,1mg/kg Dexamethasone
administration of 0,1mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block
0,2mg/kg Dexamethasone
administration of 0,2mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus 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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Leszek Romanowski, Prof.dr hab
Role: STUDY_DIRECTOR
Poznań University of Medical Sciences
Locations
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Poznan University of Medical Sciences
Poznan, , Poland
Countries
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Central Contacts
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Facility Contacts
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MAłgorzata Domagalska, PhD
Role: primary
Other Identifiers
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9/2023
Identifier Type: -
Identifier Source: org_study_id
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