Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia (BetaDexaCaudal)

Basque Health Service

Status and phase: Unknown; Phase 4

Conditions: Chronic Pain

Treatments: Drug: Dexamethasone; Drug: Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02833116

Beta-Dexa-Caudal

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups

Group Betamethasone

Experimental group

Description:

One ampule containing 12 mg of betamethasone in a syringe of 10 ml

Treatment:

Drug: Betamethasone

Group Dexamethasone

Active Comparator group

Description:

One ampule containing 4 mg of dexamethasone in a syringe os 10 ml

Treatment:

Drug: Dexamethasone