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

Early Phase 1

Completed

• Conditions: Pain, Chronic
• Interventions: Drug: Hylase versus dexmedtemodine

• Registration Number: NCT05370963
• Lead Sponsor: Minia University

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-07
• Study First Submitted QC: 2022-05-07
• Study First Posted: 2022-05-12
• Study Start: 2022-05-20
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-29
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• 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
• Surgical induced discitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyalase group	Hylase versus dexmedtemodine	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)
dexmedtemodine group	Hylase versus dexmedtemodine	Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg

Primary Outcome Measures

Name	Time	Method
pain assesment	6 months	Visual analogue scale... 0= no pain .... 10= worst pain

Secondary Outcome Measures

Name	Time	Method
acute complications	6 hours	number of patients with epidural hematoma
functional disability	6 months	Modified oswestry diability questionnaire. 0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled

Trial Locations

Locations (1)

Maher Maher; 🇪🇬 ALMinya, Egypt