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

May 7, 2022 updated by: Mina Maher, Minia University
Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Minia University Hospital
      • Minia, Minia University Hospital, Egypt, 6115
        • Recruiting
        • Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 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
up to 3 months post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional disability
Time Frame: 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
up to 3 months post injection
acute complications
Time Frame: 6 hours post-injection
number of patients developed epidural hematoma by magnetic resonance imaging
6 hours post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

September 10, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

February 26, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/219

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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