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

NCT05271721 | Completed

• 1 other identifier: R/219
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• pain score

  visual analogue pain score. pain value of (0 cm) equals no pain , and value of (10 cm) equals worst pain

  up to 6 months post-injection

Secondary Outcomes (2)

• functional disability

  up to 6 months post injection

• acute complications

  6 hours post-injection

Study Arms (3)

control group

OTHER

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

Drug: transforaminal epidural injection of dexamethasone

Magnesuim group

ACTIVE COMPARATOR

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

Drug: epidural transforaminal injection of magnesuim sulfate

Dexmedetomidine group

ACTIVE COMPARATOR

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

Interventions

epidural transforaminal injection of magnesuim sulfate DRUG

transforaminal fluroscopic guided

Also known as: floroscopic epidural injection of magnesuim

Magnesuim group

epidural transforaminal injection of dexmedtemodine DRUG

transforaminal fluroscopic guided

Also known as: fluroscopic eoidural injection of dexmedtemodine

Dexmedetomidine group

transforaminal epidural injection of dexamethasone DRUG

transforaminal fluroscopic guided

Also known as: fluroscopic epidural injection of dexamethasone

control group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Minia University Hospital, 6115, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 9, 2022
• Study Start: March 1, 2022
• Primary Completion: February 10, 2023
• Study Completion: May 1, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

EG (1)