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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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
epidural transforaminal injection of magnesuim sulfate
epidural transforaminal injection of dexmedtemodine
transforaminal epidural injection of dexamethasone
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 )

Sites / Locations

  • Minia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

control group

Magnesuim group

Dexmedetomidine group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

functional disability
Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
acute complications
number of patients developed epidural hematoma by magnetic resonance imaging

Full Information

First Posted
February 26, 2022
Last Updated
May 7, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05271721
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 10, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
Dexamethasone 4 mg (1ml) plus 40 mg ( 2ml) lidocaine 2% plus 1ml sterile saline
Arm Title
Magnesuim group
Arm Type
Active Comparator
Arm Description
. 200 mg Mg sulfate (1ml) plus 4 mg dexamethasone(1ml) plus 40mg lidocaine 2% (2ml)
Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm Description
Dexmedetmodine 50mic (0.5ml) ,4 mg dexamethasone (1ml), 40 mg lidocaine 2% (2ml) added to 4ml total volume with sterile saline .
Intervention Type
Drug
Intervention Name(s)
epidural transforaminal injection of magnesuim sulfate
Other Intervention Name(s)
floroscopic epidural injection of magnesuim
Intervention Description
transforaminal fluroscopic guided
Intervention Type
Drug
Intervention Name(s)
epidural transforaminal injection of dexmedtemodine
Other Intervention Name(s)
fluroscopic eoidural injection of dexmedtemodine
Intervention Description
transforaminal fluroscopic guided
Intervention Type
Drug
Intervention Name(s)
transforaminal epidural injection of dexamethasone
Other Intervention Name(s)
fluroscopic epidural injection of dexamethasone
Intervention Description
transforaminal fluroscopic guided
Primary Outcome Measure Information:
Title
pain score
Description
visual analogue pain score. pain value of (0 cm) equals no pain , and value of (10 cm) equals worst pain
Time Frame
up to 3 months post-injection
Secondary Outcome Measure Information:
Title
functional disability
Description
Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
Time Frame
up to 3 months post injection
Title
acute complications
Description
number of patients developed epidural hematoma by magnetic resonance imaging
Time Frame
6 hours post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mina raouf, MD
Phone
01015752424
Email
drmina2015@gmail.com
Facility Information:
Facility Name
Minia University
City
Minia
State/Province
Minia University Hospital
ZIP/Postal Code
6115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mina raouf
Phone
01015752424
Email
drmina2015@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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