Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial
NCT ID: NCT05370963
Last Updated: 2024-07-03
Study Results
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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COMPLETED
EARLY_PHASE1
100 participants
INTERVENTIONAL
2022-05-20
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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hyalase group
Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Hyaluronidase 1,500 IU reconstituted in 1 mL distilled water (HYL)
Hylase versus dexmedtemodine
fluroscopic guided lumber epidural injection
dexmedtemodine group
Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg
Hylase versus dexmedtemodine
fluroscopic guided lumber epidural injection
Interventions
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Hylase versus dexmedtemodine
fluroscopic guided lumber epidural injection
Eligibility Criteria
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Inclusion Criteria
* Both sex.
* persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence
* Patients suffering from persistent (\> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (MRI) were included for screening and enrollment.
Exclusion Criteria
* Refusal to participate
* MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
* Coagulopathic patients
* Surgical induced discitis.
30 Years
75 Years
ALL
No
Sponsors
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Minia University
OTHER
Responsible Party
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Mina Maher
Lecturer of anesthesia and ICU
Locations
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Maher Maher
ALMinya, Egypt, Egypt
Countries
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Other Identifiers
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278/5-2022
Identifier Type: -
Identifier Source: org_study_id
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