Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study

Study Overview
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Brief Summary
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use of dexmedtemodine to augment analgesia in cases of failed back surgery

Official Title
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Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study

Conditions
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Pain, Neuropathic

Intervention / Treatment
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* Drug: Hylase plus Triamcinolone plus sterile isotonic saline
* Drug: Hylase plus Dexmedetomidine plus Triamcinolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: solo group<br>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) | Drug: Hylase plus Triamcinolone plus sterile isotonic saline<br>* transforaminal fluroscopic epidural injection<br>|
| Active Comparator: dex plus hyalase group<br>Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Dexmedetomidine 0.5mic/kg + Hyaluronidase 1,500 IU reconstituted in 1 mL distilled water (HYL)+ Saline solution (2 mL) | Drug: Hylase plus Dexmedetomidine plus Triamcinolone<br>* transforaminal fluroscopic epidural injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assesment | visual analogue scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional diability | Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled | 6 months | 
| acute complications | number of patients developed epidural hematoma by magnetic resonance imaging | 6 hours after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy