Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

Study Overview
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Brief Summary
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This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.

Official Title
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Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Betamethasone
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc. Age between 18 and 80 years. Moderate to severe pain (NVS>4). Right proficient oral and written language. Exclusion Criteria: Patients with high intracranial pressure. Patients with Multiple Sclerosis. Patients with Guillain-Barré syndrome radiculopathy of vascular origin. Patients with previous lumbar surgery. Patients pregnant or lactating. Patients with allergy or intolerance to any of the drugs used. Patients with severe cognitive impairment. Patients with intrathecal injectio radiculalgia. Patients with poorly controlled major psychiatric pathology. Patients with type I diabetes or poorly controlled type II diabetes (Hb1Ac>8.5). Patients with glaucoma. Patients with caudal equine syndrome. Patients with pre-treatment with steroid injections/or local anesthetics. Patients with central canal stenosis. patients with chronic treatment with oral corticosteroids without stabilized pattern.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Group Betamethasone<br>One ampule containing 12 mg of betamethasone in a syringe of 10 ml | Drug: Betamethasone<br> <br> |
| Active Comparator: Group Dexamethasone<br>One ampule containing 4 mg of dexamethasone in a syringe os 10 ml | Drug: Dexamethasone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain. | Pain according to numerical visual pain scale. | 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life. | Quality of life according to SF-36. | 7 days, 1, 3 and 6 months. | 
| Pain. | Pain according to numerical visual pain scale. | 7 days, 1, 3 and 6 months. | 
| Adverse events. | Adverse events. | 7 days, 1, 3 and 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiculalgia, chronic pain, quality of life