CClinicalTrials.gg
CompletedNCT04527770Updated Feb 18, 2022

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

An interventional study of Dexamethasone and Midazolam injection in Pain Syndrome, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Pain Syndrome

Keywords

  • Midazolam
  • median nerve
  • dexamethasone
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's enrollment of 134 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
134 participants (actual)

Study arms

  • Active comparator
    dexamethasone group

    sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone

    Drug: Dexamethasone

  • Active comparator
    midazolam group

    sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam

    Drug: Midazolam injection

Interventions

  • DrugDexamethasone

    Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam

    Also known as: midazolam

  • DrugMidazolam injection

    intracarpal injection of midazolam and bupivacaine 0.5%

06

What researchers measure

Primary outcomes

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

    use of visual analogue score

    Time frame: up to 6 months

Secondary outcomes

  1. Subjective pain assesment

    BOSTON questionnaire

    Time frame: up to 6 months

  2. complications

    neurotoxicity, pain recurrence after injection

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

  3. Nerve electrophysiology

    sensory nerve conduction , distal motor latency.

    Time frame: up to 6 months

  4. nerve sonogram

    nerve cross sectional area.

    Time frame: up to 6 months

07

Study locations

1 site
  • Mina Maher Raouf
    ALMinya, 6115, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04527770
Lead sponsor
Minia University
Responsible party
Mina Maher (Principle investigator, Minia University) — Principal investigator
First posted
Aug 27, 2020
Start date
Sep 1, 2020
Primary completion
Mar 1, 2021
Completion
Apr 30, 2021
Last update
Feb 18, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion