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

Not Applicable

Completed

• Conditions: Pain Syndrome
• Interventions: Drug: Midazolam injection; Drug: Dexamethasone

• Registration Number: NCT04527770
• Lead Sponsor: Minia University

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-23
• Study First Posted: 2020-08-27
• Study Start: 2020-09-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• numbness or pain in the nerve distribution, nerve conduction studies (NCS) corresponding with AANEM guidelines
• Nerve cross sectional area >12mm2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam group	Midazolam injection	sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam
dexamethasone group	Dexamethasone	sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone

Primary Outcome Measures

Name	Time	Method
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%	up to 6 months	use of visual analogue score

Secondary Outcome Measures

Name	Time	Method
Subjective pain assesment	up to 6 months	BOSTON questionnaire
complications	pain recurrence after 6 months, neurotoxicity immediately after injection	neurotoxicity, pain recurrence after injection
Nerve electrophysiology	up to 6 months	sensory nerve conduction , distal motor latency.
nerve sonogram	up to 6 months	nerve cross sectional area.

Trial Locations

Locations (1)

Mina Maher Raouf; 🇪🇬 ALMinya, Egypt