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

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 .

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Drug: Hylase versus dexmedtemodine

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • ALMinya, Egypt, 6115
    • Maher Maher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: hyalase group; 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 versus dexmedtemodine; fluroscopic guided lumber epidural injection
Active Comparator: dexmedtemodine group; Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg	Drug: Hylase versus dexmedtemodine; fluroscopic guided lumber epidural injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain assesment	Visual analogue scale... 0= no pain .... 10= worst pain	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 7, 2022
• First Submitted That Met QC Criteria: May 7, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 278/5-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No