Magnesium as Adjuvant for Sciatic Block

Study Overview
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Brief Summary
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The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time.

Detailed Description
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Patients are randomly divided into two groups: group M (Ropivacaina 7,5 mg/ml with Mg 4 mg/Kg)and groupC (without Mg). Standard monitoring is applied to each patient in perioperative period. An indipendent observer collect data: time to perform block, sensitivity onset,motor onset, pain during surgery and complication. In the post-operative period till 24 hours for each patient is evaluated off-set time, pain and analgesic consumption.

Official Title
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Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.

Conditions
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Hallux Valgus

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: given consent allux valgus correction surgery Exclusion Criteria: allergy to local anesthetic infection in the site of puncture

Ages Eligible for Study
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Minimum 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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine Magnesium sulfate<br>Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg. Sciatic block at popliteal level. | Drug: Magnesium Sulfate<br>* Mg used with ropivacaine for sciatic nerve blick<br>|
| Active Comparator: Ropivacaine<br>Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG | Drug: Ropivacaine<br>* Ropivacaine 7,5 mg/ml used for sciatic nerve block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Mg as adjuvant to local anesthetic | We evaluate if Mg affects onset and offset time of ropivacaine 7,5 mg/ml in sciatic block at popliteal level | Till 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale | 3 hours | 
| Post-operative analgesic consumption | We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period. | till 24 hours | 
| Post-operative pain | Evaluation of pain with NRS scale | 6 hours | 
| post-operative pain | Evaluation of pain with NRS scale | 12 hours | 
| Post-operative pain | Evaluation of pain with NRS scale | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local anesthetic adjuvant,, Magnesium solfatus,, Sciatic block