NCT05370963

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

May 7, 2022

Last Update Submit

June 29, 2024

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • pain assesment

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

    6 months

Secondary Outcomes (2)

  • functional disability

    6 months

  • acute complications

    6 hours

Study Arms (2)

hyalase 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 versus dexmedtemodine

dexmedtemodine group

ACTIVE COMPARATOR

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

Drug: Hylase versus dexmedtemodine

Interventions

Hylase versus dexmedtemodineDRUG

fluroscopic guided lumber epidural injection

dexmedtemodine grouphyalase group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Surgical induced discitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maher Maher

ALMinya, Egypt, 6115, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

May 7, 2022

First Posted

May 12, 2022

Study Start

May 20, 2022

Primary Completion

May 30, 2023

Study Completion

June 1, 2023

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations

EG(1)