Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Study Overview
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Brief Summary
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Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery

Detailed Description
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This study is proposed to explore the effect of systemic dexamethasone on the duration of popliteal nerve block for analgesia after pediatric ankle surgery. After ankle or 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 anesthesia is particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect. There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge 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 at the same time covers the need for good pain relief and fast recovery postoperatively.

Official Title
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Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Conditions
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Ankle Disease, Foot Deformities, Foot Diseases, Cerebral Palsy

Intervention / Treatment
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* Drug: Sodium Chloride 0.9% Inj
* Drug: 0,1mg/kg Dexamethasone
* Drug: 0,2mg/kg Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children scheduled for ankle/foot 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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Accepts Healthy Volunteers

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 injection<br>5ml of 0,9% sodium chloride - before the popliteal nerve block | Drug: Sodium Chloride 0.9% Inj<br>* administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block<br>* Other names: Placebo;|
| Active Comparator: 0,1mg/kg Dexamethasone<br>0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block | Drug: 0,1mg/kg Dexamethasone<br>* administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block<br>* Other names: small dose;|
| Active Comparator: 0,2mg/kg Dexamethasone<br>0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block | Drug: 0,2mg/kg Dexamethasone<br>* administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block<br>* Other names: large dose;|

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 | Toe 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 |