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

NCT ID: NCT04527770

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-04-30

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

Conditions

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Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
both drugs are the same colour and volume injected by a staff member not aware of study design

Study Groups

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dexamethasone group

sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam

midazolam group

sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam

Group Type ACTIVE_COMPARATOR

Midazolam injection

Intervention Type DRUG

intracarpal injection of midazolam and bupivacaine 0.5%

Interventions

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Dexamethasone

Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam

Intervention Type DRUG

Midazolam injection

intracarpal injection of midazolam and bupivacaine 0.5%

Intervention Type DRUG

Other Intervention Names

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midazolam

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mina Maher Raouf

ALMinya, Egypt, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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644/4-2020

Identifier Type: -

Identifier Source: org_study_id

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