Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Study Overview
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Brief Summary
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Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Detailed Description
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This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. After scoliosis 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 or Dexmedetomidine, 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 and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children. In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic. The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Official Title
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Dexamethasone vs. Dexmedetomidine for Erector Spine Plane Block in Pain Management After Pediatric Idiopathic Scoliosis Surgery.

Conditions
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Scoliosis Idiopathic, Scoliosis; Adolescence

Intervention / Treatment
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* Drug: 0.9% sodium chloride
* Drug: Dexamethasone
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children scheduled for idiopathic scoliosis surgery age >10 and <18 years Exclusion Criteria: age < 10 years age < 18 years 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: 10 Years
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 |
| --- | --- |
| Placebo Comparator: Placebo<br>0.2% ropivacaine for erector spinae plane block | Drug: 0.9% sodium chloride<br>* administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block<br>* Other names: placebo;|
| Active Comparator: Dexamethasone<br>0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block | Drug: Dexamethasone<br>* administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block<br>|
| Active Comparator: Dexmedetomidine<br>0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block | Drug: Dexmedetomidine<br>* administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block<br>|

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 | 
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 4 hours after surgery | 
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 8 hours after surgery | 
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 12 hours after surgery | 
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 16 hours after surgery | 
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 20 hours after surgery | 
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 24 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] |