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OpenTrials
Completed

NCT Number: NCT05271721

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

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, Minia University Hospital, 6115, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

epidural transforaminal injection of magnesuim sulfate

Drug

transforaminal fluroscopic guided

Other names: floroscopic epidural injection of magnesuim

epidural transforaminal injection of dexmedtemodine

Drug

transforaminal fluroscopic guided

Other names: fluroscopic eoidural injection of dexmedtemodine

transforaminal epidural injection of dexamethasone

Drug

transforaminal fluroscopic guided

Other names: fluroscopic epidural injection of dexamethasone

Primary outcomes

  1. pain score

    Time frame: 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 outcomes

  1. functional disability

    Time frame: 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

  2. acute complications

    Time frame: 6 hours post-injection

    number of patients developed epidural hematoma by magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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