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

NCT ID: NCT05271721

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-05-01

Brief Summary

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

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control group

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

Group Type OTHER

transforaminal epidural injection of dexamethasone

Intervention Type DRUG

transforaminal fluroscopic guided

Magnesuim group

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

Group Type ACTIVE_COMPARATOR

epidural transforaminal injection of magnesuim sulfate

Intervention Type DRUG

transforaminal fluroscopic guided

Dexmedetomidine group

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

Group Type ACTIVE_COMPARATOR

epidural transforaminal injection of dexmedtemodine

Intervention Type DRUG

transforaminal fluroscopic guided

Interventions

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epidural transforaminal injection of magnesuim sulfate

transforaminal fluroscopic guided

Intervention Type DRUG

epidural transforaminal injection of dexmedtemodine

transforaminal fluroscopic guided

Intervention Type DRUG

transforaminal epidural injection of dexamethasone

transforaminal fluroscopic guided

Intervention Type DRUG

Other Intervention Names

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floroscopic epidural injection of magnesuim fluroscopic eoidural injection of dexmedtemodine fluroscopic epidural injection of dexamethasone

Eligibility Criteria

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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 )
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia University

Minya, Minia University Hospital, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R/219

Identifier Type: -

Identifier Source: org_study_id

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