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

Primary Purpose

Pain, Chronic

Status

Recruiting

Phase

Early Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Hylase versus dexmedtemodine

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

30 Years - 75 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
Surgical induced discitis.

Sites / Locations

Maher MaherRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

hyalase group

dexmedtemodine 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) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg

Outcomes

Primary Outcome Measures

pain assesment

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

Secondary Outcome Measures

functional disability

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

acute complications

number of patients with epidural hematoma

Full Information

NCT ID

NCT05370963

First Posted

May 7, 2022

Last Updated

May 21, 2022

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05370963

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

October 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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Chronic

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

hyalase 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

dexmedtemodine group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hylase versus dexmedtemodine

Intervention Description

fluroscopic guided lumber epidural injection

Primary Outcome Measure Information:

Title

pain assesment

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

functional disability

Description

Modified oswestry diability 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 with epidural hematoma

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 Surgical induced discitis.

Facility Information:

Facility Name

Maher Maher

City

ALMinya

ZIP/Postal Code

6115

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

mina M maher

Phone

01015752424

drmina2015@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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