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

Primary Purpose

Pain, Neuropathic

Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Hylase plus Triamcinolone plus sterile isotonic saline
Hylase plus Dexmedetomidine plus Triamcinolone
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neuropathic focused on measuring neuropathy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

solo group

dex plus hyalase group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

pain assesment
visual analogue scale

Secondary Outcome Measures

functional diability
Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
acute complications
number of patients developed epidural hematoma by magnetic resonance imaging

Full Information

First Posted
April 21, 2022
Last Updated
June 16, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05349448
Brief Title
Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study
Official Title
Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic
Keywords
neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
solo group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
dex plus hyalase group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Hylase plus Triamcinolone plus sterile isotonic saline
Intervention Description
transforaminal fluroscopic epidural injection
Intervention Type
Drug
Intervention Name(s)
Hylase plus Dexmedetomidine plus Triamcinolone
Intervention Description
transforaminal fluroscopic epidural injection
Primary Outcome Measure Information:
Title
pain assesment
Description
visual analogue scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
functional diability
Description
Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
Time Frame
6 months
Title
acute complications
Description
number of patients developed epidural hematoma by magnetic resonance imaging
Time Frame
6 hours after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mina raouf
Phone
01015752424
Email
drmina2015@gmail.com
Facility Information:
Facility Name
Minia University
City
ALMinya
State/Province
Minia
ZIP/Postal Code
6115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mina raouf
Phone
01015752424
Email
drmina2015@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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