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Clinical trial

Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial

ID
Name
278/5-2022
Description
hyalase and dexmedtemodine are well known adjuvants given epidurally to alleviate chronic back pain. Use in failed back surgery is an up to date field to hasten analgesia and py off recurrence .
Trial arms
Trial start
2022-05-20
Estimated PCD
2023-05-30
Trial end
2023-06-01
Status
Completed
Phase
Early phase I
Treatment
Hylase versus dexmedtemodine
fluroscopic guided lumber epidural injection
Arms:
dexmedtemodine group, hyalase group
Size
100
Primary endpoint
pain assesment
6 months
Eligibility criteria
Inclusion Criteria: * Age group. 25-75ys old * 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: * Diabetic patients. * Refusal to participate * MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy . * Coagulopathic patients * Surgical induced discitis.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2024-07-02

1 organization

1 product

2 indications

Organization
Minia University
Product
Hylase vs Dexmedetomidine
Indication
Pain
Indication
Chronic