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

Pain, Neuropathic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349448
• Other study ID #: 270/3-2022
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 28, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: June 2022
• Source: Minia University
• Contact: mina raouf
• Phone: 01015752424
• Email: drmina2015[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 10, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pain, Neuropathic

Intervention

Drug:
• Hylase plus Triamcinolone plus sterile isotonic saline
transforaminal fluroscopic epidural injection
• Hylase plus Dexmedetomidine plus Triamcinolone
transforaminal fluroscopic epidural injection

Locations

Country	Name	City	State
Egypt	Minia University	ALMinya	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain assesment	visual analogue scale	6 months
Secondary	functional diability	Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled	6 months
Secondary	acute complications	number of patients developed epidural hematoma by magnetic resonance imaging	6 hours after injection