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

Early Phase 1

• Conditions: Pain, Neuropathic
• Interventions: Drug: Hylase plus Dexmedetomidine plus Triamcinolone; Drug: Hylase plus Triamcinolone plus sterile isotonic saline

• Registration Number: NCT05349448
• Lead Sponsor: Minia University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-11-20
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dex plus hyalase group	Hylase plus Dexmedetomidine plus Triamcinolone	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)
solo group	Hylase plus Triamcinolone plus sterile isotonic saline	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)

Primary Outcome Measures

Name	Time	Method
pain assesment	6 months	visual analogue scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Minia University; 🇪🇬 ALMinya, Minia, Egypt