Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Study Overview
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Brief Summary
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Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Detailed Description
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This study is proposed to explore the effect of perineurial Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery. 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 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.

Official Title
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Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Conditions
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Wrist Disease, Hand Injuries, Wrist Injuries, Hand Disease, Hand Injuries and Disorders

Intervention / Treatment
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* Drug: Placebo
* Drug: 0.1mg/kg Dexamethasone
* Drug: 0.05mg/kg Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children scheduled for hand/wrist surgery body weight > 5kg Exclusion Criteria: infection at the site of the regional blockade coagulation disorders immunodeficiency ASA= or >4 steroid medication in regular use

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo<br>0.2% ropivacaine for supraclavicular brachial plexus block | Drug: Placebo<br>* administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the supraclavicular brachial plexus block<br>* Other names: 0.9% sodium chloride;|
| Active Comparator: 0.1mg/kg Dexamethasone<br>0,1mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus block | Drug: 0.1mg/kg Dexamethasone<br>* administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the supraclavicular brachial plexus block<br>* Other names: large dose dexamethasone;|
| Active Comparator: 0,05mg/kg dexamethasone<br>0,05mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus block | Drug: 0.05mg/kg Dexamethasone<br>* administration of 0.5ml/kg of 0,2% ropivacaine with 0.05mg/kg Dexamethasone for the supraclavicular brachial plexus block<br>* Other names: small dose dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first need of opiate | Time after surgery when the patient needs opiate for the first time | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Total opiate consumption after surgery | 48 hours | 
| Pain score | children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale) | 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery | 
| Blood glucose | Blood glucose every 24 hour during hospitalization | 24 and 48 hours after surgery | 
| NLR | Neutrophil-to-lymphocyte ratio | 24 and 48 hours after surgery | 
| PLR | Platelet-to-lymphocyte ratio | 24 and 48 hours after surgery | 
| Mobilisation | Finger movement every 4 hours | 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery |