Pain, NeuropathicEarly Phase 1NCT05349448
Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study
A Early Phase 1 study testing Hylase plus Triamcinolone plus sterile isotonic saline and Hylase plus Dexmedetomidine plus Triamcinolone in people with Pain, Neuropathic, run by Minia University at 1 site in Egypt.
Trial summary
use of dexmedtemodine to augment analgesia in cases of failed back surgery Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pain, Neuropathic
- What is being tested?
- Hylase plus Triamcinolone plus sterile isotonic saline and Hylase plus Dexmedetomidine plus Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2022to 10 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetic patients.
- Refusal to participate
- MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
- Coagulopathic patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University
ALMinya, Minya Governorate, 6115
mina raouf, 01015752424, drmina2015@gmail.com
About this study
use of dexmedtemodine to augment analgesia in cases of failed back surgery
- Conditions
- Pain, Neuropathic
- Being tested
- Hylase plus Triamcinolone plus sterile isotonic saline, Hylase plus Dexmedetomidine plus Triamcinolone
- Keywords
- neuropathy
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylase plus Triamcinolone plus sterile isotonic salineDrug
transforaminal fluroscopic epidural injection
Hylase plus Dexmedetomidine plus TriamcinoloneDrug
transforaminal fluroscopic epidural injection
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Hylase plus Dexmedetomidine plus Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assesment
visual analogue scale
Measured: 6 months
Secondary outcomes (2)
functional diability
Modified Oswestry Disability Questionnaire....0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled
Measured: 6 months
acute complications
number of patients developed epidural hematoma by magnetic resonance imaging
Measured: 6 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start28 Mar 2022
- Primary completion20 Nov 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349448
- Sponsor's protocol ID
- 270/3-2022
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05349448
- Acronym / sponsor ID
- 270/3-2022
- Conditions
- Pain, Neuropathic
- Keywords
- neuropathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
use of dexmedtemodine to augment analgesia in cases of failed back surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solo group | Active comparator | Drug: Hylase plus Triamcinolone plus sterile isotonic salineBupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Hyaluronidase 1,500 IU reconstituted in 1 mL distilled water (HYL) |
| dex plus hyalase group | Active comparator | Drug: Hylase plus Dexmedetomidine plus TriamcinoloneBupivacaine 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) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Diabetic patients.
- Refusal to participate
- MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
- Coagulopathic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hylase plus Triamcinolone plus sterile isotonic salinetransforaminal fluroscopic epidural injection | Drug | solo group |
| Hylase plus Dexmedetomidine plus Triamcinolonetransforaminal fluroscopic epidural injection | Drug | dex plus hyalase group |
Primary outcome
pain assesment
Time frame: 6 months
visual analogue scale
2 secondary outcomes
functional diability
Time frame: 6 months
acute complications
Time frame: 6 hours after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hylase plus Triamcinolone plus sterile isotonic saline and Hylase plus Dexmedetomidine plus Triamcinolone in people with Pain, Neuropathic, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mina raouf (01015752424, drmina2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assesment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.