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OpenTrials
Completed

NCT Number: NCT05370963

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 .

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Maher Maher

ALMinya, Egypt, 6115

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hylase versus dexmedtemodine

Drug

fluroscopic guided lumber epidural injection

Primary outcomes

  1. pain assesment

    Time frame: 6 months

    Visual analogue scale... 0= no pain .... 10= worst pain

Secondary outcomes

  1. functional disability

    Time frame: 6 months

    Modified oswestry diability questionnaire. 0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled

  2. acute complications

    Time frame: 6 hours

    number of patients with epidural hematoma

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 12, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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