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

NCT04527770 | Completed

• 1 other identifier: 644/4-2020
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Syndrome

Keywords

Midazolam; median nerve; dexamethasone

Outcome Measures

Primary Outcomes (1)

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

  use of visual analogue score

  up to 6 months

Secondary Outcomes (4)

• Subjective pain assesment

  up to 6 months

• complications

  pain recurrence after 6 months, neurotoxicity immediately after injection

• Nerve electrophysiology

  up to 6 months

• nerve sonogram

  up to 6 months

Study Arms (2)

dexamethasone group

ACTIVE COMPARATOR

sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone

Drug: Dexamethasone

midazolam group

ACTIVE COMPARATOR

sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam

Drug: Midazolam injection

Interventions

Dexamethasone DRUG

Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam

Also known as: midazolam

dexamethasone group

Midazolam injection DRUG

intracarpal injection of midazolam and bupivacaine 0.5%

midazolam group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Mina Maher Raouf

ALMinya, Egypt, 6115, Egypt

Location

MeSH Terms

Conditions

Somatoform Disorders

Interventions

Dexamethasone; Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: both drugs are the same colour and volume injected by a staff member not aware of study design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 27, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 30, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

EG (1)