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

NCT ID: NCT05349448

Last Updated: 2022-06-22

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2022-12-10

Brief Summary

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

Detailed Description

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Conditions

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Pain, Neuropathic

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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solo 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 plus Triamcinolone plus sterile isotonic saline

Intervention Type DRUG

transforaminal fluroscopic epidural injection

dex plus hyalase group

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)

Group Type ACTIVE_COMPARATOR

Hylase plus Dexmedetomidine plus Triamcinolone

Intervention Type DRUG

transforaminal fluroscopic epidural injection

Interventions

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Hylase plus Triamcinolone plus sterile isotonic saline

transforaminal fluroscopic epidural injection

Intervention Type DRUG

Hylase plus Dexmedetomidine plus Triamcinolone

transforaminal fluroscopic 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 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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Minia University

ALMinya, Minya Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mina raouf

Role: CONTACT

01015752424

Facility Contacts

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mina raouf

Role: primary

01015752424

Other Identifiers

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270/3-2022

Identifier Type: -

Identifier Source: org_study_id

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