Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

Chronic Pain Clinical Trial

— BetaDexaCaudal  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02833116
• Other study ID #: Beta-Dexa-Caudal
• Status: Recruiting
• Phase: Phase 4
• First received: July 12, 2016
• Last updated: October 24, 2016
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: October 2016
• Source: Basque Health Service
• Contact: Enrique Barez
• Phone: +34945007246
• Email: ENRIQUEMANUEL.BAREZHERNANDEZ[@]osakidetza.eus
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Basque Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 2020
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Betamethasone

• Dexamethasone

Locations

Country	Name	City	State
Spain	Enrique Barez	Vitoria-Gasteiz	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain.	Pain according to numerical visual pain scale.	3 months.	No
Secondary	Quality of life.	Quality of life according to SF-36.	7 days, 1, 3 and 6 months.	No
Secondary	Pain.	Pain according to numerical visual pain scale.	7 days, 1, 3 and 6 months.	No
Secondary	Adverse events.	Adverse events.	7 days, 1, 3 and 6 months.	Yes