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

Minia University

Status and phase: Enrolling; Early Phase 1

Conditions: Pain, Neuropathic

Treatments: Drug: Hylase plus Triamcinolone plus sterile isotonic saline; Drug: Hylase plus Dexmedetomidine plus Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05349448

270/3-2022

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

solo group

Active Comparator group

Description:

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)

Treatment:

Drug: Hylase plus Triamcinolone plus sterile isotonic saline

dex plus hyalase group

Active Comparator group

Description:

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)

Treatment:

Drug: Hylase plus Dexmedetomidine plus Triamcinolone