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

Sponsor

Minia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05349448

Collaborator

(none)

100

Enrollment

Location

Arms

8.4

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Neuropathic	Drug: Hylase plus Triamcinolone plus sterile isotonic saline Drug: Hylase plus Dexmedetomidine plus Triamcinolone	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Nov 20, 2022

Anticipated Study Completion Date :

Dec 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	Drug: Hylase plus Triamcinolone plus sterile isotonic saline transforaminal fluroscopic epidural injection
Active Comparator: 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)	Drug: Hylase plus Dexmedetomidine plus Triamcinolone transforaminal fluroscopic epidural injection

Arm

Intervention/Treatment

Active Comparator: 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)

Drug: Hylase plus Triamcinolone plus sterile isotonic saline

transforaminal fluroscopic epidural injection

Active Comparator: 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)

Drug: Hylase plus Dexmedetomidine plus Triamcinolone

transforaminal fluroscopic epidural injection

Outcome Measures

Primary Outcome Measures

pain assesment [6 months]
visual analogue scale

Secondary Outcome Measures

functional diability [6 months]
Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
acute complications [6 hours after injection]
number of patients developed epidural hematoma by magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.