Skip to main content
OpenTrials
Completed

NCT Number: NCT04527770

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Syndrome Mental Disorders Somatoform Disorders

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mina Maher Raouf

ALMinya, Egypt, 6115

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam

Other names: midazolam

Midazolam injection

Drug

intracarpal injection of midazolam and bupivacaine 0.5%

Primary outcomes

  1. comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%

    Time frame: up to 6 months

    use of visual analogue score

Secondary outcomes

  1. Subjective pain assesment

    Time frame: up to 6 months

    BOSTON questionnaire

  2. complications

    Time frame: pain recurrence after 6 months, neurotoxicity immediately after injection

    neurotoxicity, pain recurrence after injection

  3. Nerve electrophysiology

    Time frame: up to 6 months

    sensory nerve conduction , distal motor latency.

  4. nerve sonogram

    Time frame: up to 6 months

    nerve cross sectional area.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2020
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.