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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271721
• Other study ID #: R/219
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2022
• Source: Minia University
• Contact: mina raouf, MD
• Phone: 01015752424
• Email: drmina2015[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2022
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• epidural transforaminal injection of magnesuim sulfate
transforaminal fluroscopic guided
• epidural transforaminal injection of dexmedtemodine
transforaminal fluroscopic guided
• transforaminal epidural injection of dexamethasone
transforaminal fluroscopic guided

Locations

Country	Name	City	State
Egypt	Minia University	Minia	Minia University Hospital

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	acute complications	number of patients developed epidural hematoma by magnetic resonance imaging	6 hours post-injection