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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04527770
Other study ID # 644/4-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date April 30, 2021

Study information

Verified date February 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date April 30, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam
Midazolam injection
intracarpal injection of midazolam and bupivacaine 0.5%

Locations

Country Name City State
Egypt Mina Maher Raouf ALMinya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5% use of visual analogue score up to 6 months
Secondary Subjective pain assesment BOSTON questionnaire up to 6 months
Secondary complications neurotoxicity, pain recurrence after injection pain recurrence after 6 months, neurotoxicity immediately after injection
Secondary Nerve electrophysiology sensory nerve conduction , distal motor latency. up to 6 months
Secondary nerve sonogram nerve cross sectional area. up to 6 months
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