Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients

Study Overview
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Brief Summary
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midazolam and dexamethasone both can counteract chronic pain. either via GABA mimetic action or via anti prostaglandins

Detailed Description
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Entrapement syndrome - namely median nerve compression in carpal tunnel syndrome - causes chronic pain that can be refractory to medical treatment . Ultrasound guided hydrodissection is an option for alleviating pain . Recurrence is the main side effect of injection. We try in this research to prevent recurrence rate . Midazolam and dexamethasone both are used in chronic pain . Midazolm act by GABA mimetic action while dexamethasone act by decrease interleukin formation

Official Title
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Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients

Conditions
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Pain Syndrome

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Midazolam injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines Nerve cross sectional area >12mm2 Exclusion Criteria: Refusal to participate History of operation in median nerve.were patient refusal to participate, pain recurrence after previous injection and severe symptoms requiring surgical release, diabetic patients

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone group<br>sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone | Drug: Dexamethasone<br>* Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam<br>* Other names: midazolam;|
| Active Comparator: midazolam group<br>sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam | Drug: Midazolam injection<br>* intracarpal injection of midazolam and bupivacaine 0.5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5% | use of visual analogue score | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain assesment | BOSTON questionnaire | up to 6 months | 
| complications | neurotoxicity, pain recurrence after injection | pain recurrence after 6 months, neurotoxicity immediately after injection | 
| Nerve electrophysiology | sensory nerve conduction , distal motor latency. | up to 6 months | 
| nerve sonogram | nerve cross sectional area. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, median nerve, dexamethasone