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

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05370963
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.3
• Patients Per Site Per Month: 12

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic	Drug: Hylase versus dexmedtemodine	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: Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial
• Actual Study Start Date: Jan 20, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: hyalase 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 versus dexmedtemodine; fluroscopic guided lumber epidural injection
Active Comparator: dexmedtemodine group Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg	Drug: Hylase versus dexmedtemodine; fluroscopic guided lumber epidural injection

Outcome Measures

Primary Outcome Measures

1. pain assesment [6 months]

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

Secondary Outcome Measures

1. functional disability [6 months]

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

2. acute complications [6 hours]

   number of patients with epidural hematoma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maher Maher	ALMinya		Egypt	6115

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mina Maher, Lecturer of anesthesia and ICU, Minia University
• ClinicalTrials.gov Identifier: NCT05370963
• Other Study ID Numbers: 278/5-2022
• First Posted: May 12, 2022
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of May 26, 2022