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

NCT05349448 | Unknown Early Phase 1

• 1 other identifier: 270/3-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Neuropathic

Keywords

neuropathy

Outcome Measures

Primary Outcomes (1)

• pain assesment

  visual analogue scale

  6 months

Secondary Outcomes (2)

• functional diability

  6 months

• acute complications

  6 hours after injection

Study Arms (2)

solo group

ACTIVE COMPARATOR

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

dex plus hyalase group

ACTIVE COMPARATOR

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

Interventions

Hylase plus Triamcinolone plus sterile isotonic saline DRUG

transforaminal fluroscopic epidural injection

solo group

Hylase plus Dexmedetomidine plus Triamcinolone DRUG

transforaminal fluroscopic epidural injection

dex plus hyalase group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetic patients.
• Refusal to participate
• MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
• Coagulopathic patients

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

ALMinya, Minya Governorate, 6115, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

hylase; Triamcinolone; Dexmedetomidine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

mina raouf

CONTACT

01015752424; drmina2015@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: March 28, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 10, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

EG (1)