- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
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
- Name: Mina Raouf, MD
- Phone Number: 01015752424
- Email: drmina2015@gmail.com
Study Locations
-
-
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
|
transforaminal fluroscopic guided
Other Names:
|
Active Comparator: Magnesuim group
. 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml)
|
transforaminal fluroscopic guided
Other Names:
|
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 .
|
transforaminal fluroscopic guided
Other Names:
|
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
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
- Pain
- Neurologic Manifestations
- Chronic Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
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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