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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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05349448
Enrollment
100
Registered
2022-04-27
Start date
2022-03-28
Completion date
2022-12-10
Last updated
2022-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Neuropathic

Keywords

neuropathy

Brief summary

use of dexmedtemodine to augment analgesia in cases of failed back surgery

Interventions

DRUGHylase plus Triamcinolone plus sterile isotonic saline

transforaminal fluroscopic epidural injection

DRUGHylase plus Dexmedetomidine plus Triamcinolone

transforaminal fluroscopic epidural injection

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain assesment6 monthsvisual analogue scale

Secondary

MeasureTime frameDescription
functional diability6 monthsModified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
acute complications6 hours after injectionnumber of patients developed epidural hematoma by magnetic resonance imaging

Countries

Egypt

Contacts

Primary Contactmina raouf
drmina2015@gmail.com01015752424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026