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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Drug: epidural transforaminal injection of magnesuim sulfate; Drug: epidural transforaminal injection of dexmedtemodine; Drug: transforaminal epidural injection of dexamethasone

• Registration Number: NCT05271721
• Lead Sponsor: Minia University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-26
• Study Start: 2022-03-01
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-09
• Primary Completion: 2023-02-10
• Study Completion: 2023-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesuim group	epidural transforaminal injection of magnesuim sulfate	. 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml)
Dexmedetomidine group	epidural transforaminal injection of dexmedtemodine	Dexmedetmodine 50mic (0.5ml) ,4 mg dexamethasone (1ml), 40 mg lidocaine 2% (2ml) added to 4ml total volume with sterile saline .
control group	transforaminal epidural injection of dexamethasone	Dexamethasone 4 mg (1ml) plus 40 mg ( 2ml) lidocaine 2% plus 1ml sterile saline

Primary Outcome Measures

Name	Time	Method
pain score	up to 6 months post-injection	visual analogue pain score. pain value of (0 cm) equals no pain , and value of (10 cm) equals worst pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minia, Minia University Hospital, Egypt