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

NCT ID: NCT05370963

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2023-06-01

Brief Summary

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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

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Conditions

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Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Hylase versus dexmedtemodine

Intervention Type DRUG

fluroscopic guided lumber epidural injection

dexmedtemodine group

Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg

Group Type ACTIVE_COMPARATOR

Hylase versus dexmedtemodine

Intervention Type DRUG

fluroscopic guided lumber epidural injection

Interventions

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Hylase versus dexmedtemodine

fluroscopic guided lumber epidural injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maher Maher

ALMinya, Egypt, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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278/5-2022

Identifier Type: -

Identifier Source: org_study_id

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