- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05184881
Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study.
The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block.
Grouping:
- Group M: cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
- Group R: cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Mansoura, Egypt
- Yahya Wahba
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients more than 18 years old of both genders with cervical facet joint arthropathy confirmed by magnetic resonance imaging (MRI) and neck manual examination and not responding to conservative treatments
- numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
- American society of Anesthesiology Physical Status class I and II,
- Body mass index ˂ 30
Exclusion Criteria:
- The exclusion criteria are patient refusal
- local or systemic sepsis, coagulopathy,
- unstable cardiovascular and respiratory diseases,
- previous neurological deficits,
- history of psychiatric disorders,
- history of drug abuse,
- distorted local anatomy,
- those who were allergic to the used medications .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group medial branch block
cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
|
1- Cervical medial branch block: will be performed on prone-positioned patients using a posterior approach.
Under fluoroscopic visualization, after identification of the waists of the articular pillars at the desired levels, each medial branch block was administered with a 25-gauge, 3.5-inch spinal needle.
When the place of the needle tip will be confirmed at the mid-point of the waists of articular pillars, 1 ml of the mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml) will be injected at each level.
|
Active Comparator: Group retrolaminar block
cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
|
2- Cervical retrolaminar block: will be performed on prone-positioned patients.
Under fluoroscopic visualization, after identification of the lamina at the desired level, a 25-gauge, 3.5-inch spinal needle was introduced and when the needle tip will be confirmed at the posterior aspect of the cervical lamina corresponding to cervical facet arthropathy level.
5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) will be injected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical rating score
Time Frame: before injection
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from zero to 10 (where 0 no pain, 10 the worst pain)
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before injection
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Numerical rating score
Time Frame: after 2 weeks from injection
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from zero to 10 (where 0 no pain, 10 the worst pain)
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after 2 weeks from injection
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Numerical rating score
Time Frame: after 2 month from block
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from zero to 10 (where 0 no pain, 10 the worst pain)
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after 2 month from block
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Numerical rating score
Time Frame: after 3 month from block
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from zero to 10 (where 0 no pain, 10 the worst pain)
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after 3 month from block
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck disability index
Time Frame: before injection
|
Each of the 10 items scores from 0 to 5. The maximum score is 50.
0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
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before injection
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Neck disability index
Time Frame: after 2 weeks from injection
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Each of the 10 items scores from 0 to 5. The maximum score is 50.
0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
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after 2 weeks from injection
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.21.11.1534
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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