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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

Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05271721
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
7
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: epidural transforaminal injection of magnesuim sulfate
  • Drug: epidural transforaminal injection of dexmedtemodine
  • Drug: transforaminal epidural injection of dexamethasone
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Sep 10, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: control group

Dexamethasone 4 mg (1ml) plus 40 mg ( 2ml) lidocaine 2% plus 1ml sterile saline

Drug: transforaminal epidural injection of dexamethasone
transforaminal fluroscopic guided
Other Names:
  • fluroscopic epidural injection of dexamethasone

    		•
    Active Comparator: Magnesuim group

    . 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml)

    Drug: epidural transforaminal injection of magnesuim sulfate
    transforaminal fluroscopic guided
    Other Names:
  • floroscopic epidural injection of magnesuim

    		•
    Active Comparator: Dexmedetomidine group

    Dexmedetmodine 50mic (0.5ml) ,4 mg dexamethasone (1ml), 40 mg lidocaine 2% (2ml) added to 4ml total volume with sterile saline .

    Drug: epidural transforaminal injection of dexmedtemodine
    transforaminal fluroscopic guided
    Other Names:
  • fluroscopic eoidural injection of dexmedtemodine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain score [up to 3 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

    1. functional disability [up to 3 months post injection]

      Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled

    2. acute complications [6 hours post-injection]

      number of patients developed epidural hematoma by magnetic resonance imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 )

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Minia University Minia Minia University Hospital Egypt 6115

    Sponsors and Collaborators

    • Minia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mina Maher, Lecturer of anesthesia and ICU, Minia University
    ClinicalTrials.gov Identifier:
    NCT05271721
    Other Study ID Numbers:
    • R/219
    First Posted:
    Mar 9, 2022
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chronic Pain
    Dexamethasone
    Dexamethasone acetate
    BB 1101

    Study Results

    No Results Posted as of May 10, 2022