Trans-foraminal Lumbar Epidural Injection of Dexmedetomidine Against Magnesium Sulfate When Combined With Dexamethasone in Uni-lateral Lower Limb Radicular Pain. Multi-centeric Comparative Study

Study Overview
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Brief Summary
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Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate

Official Title
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Trans-foraminal Lumbar Epidural Injection of Dexmedetomidine Against Magnesium Sulfate When Combined With Dexamethasone in Uni-lateral Lower Limb Radicular Pain. Multi-centeric Comparative Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: epidural transforaminal injection of magnesuim sulfate
* Drug: epidural transforaminal injection of dexmedtemodine
* Drug: transforaminal epidural injection of dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group. 25-75ys old Both sex. Lumber disc protrusion at one or two segments on MRI. Chronic lumbar radiculer pain for more than 6 weeks refractory to medical treatment for at least 4 weeks. . Positve leg rising test at 30-70 degrees. Exclusion Criteria: Diabetic candidates ( type Ior II). Patient refusal. MRI with disc sequestration. Neurological examination revealed foot drop, neuropathic ulcers Myelopathic or scoliotic patients, . Coagulopathic patients ( cirrhotic patients, on anti-coagulation )

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control group<br>Dexamethasone 4 mg (1ml) plus 40 mg ( 2ml) lidocaine 2% plus 1ml sterile saline | Drug: transforaminal epidural injection of dexamethasone<br>* transforaminal fluroscopic guided<br>* Other names: fluroscopic epidural injection of dexamethasone;|
| Active Comparator: Magnesuim group<br>. 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml) | Drug: epidural transforaminal injection of magnesuim sulfate<br>* transforaminal fluroscopic guided<br>* Other names: floroscopic epidural injection of magnesuim;|
| Active Comparator: Dexmedetomidine group<br>Dexmedetmodine 50mic (0.5ml) ,4 mg dexamethasone (1ml), 40 mg lidocaine 2% (2ml) added to 4ml total volume with sterile saline . | Drug: epidural transforaminal injection of dexmedtemodine<br>* transforaminal fluroscopic guided<br>* Other names: fluroscopic eoidural injection of dexmedtemodine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | visual analogue pain score. pain value of (0 cm) equals no pain , and value of (10 cm) equals worst pain | up to 3 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional disability | Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled | up to 3 months post injection | 
| acute complications | number of patients developed epidural hematoma by magnetic resonance imaging | 6 hours post-injection |