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

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT04527770

Collaborator

(none)

134

Enrollment

Location

Arms

7.9

Actual Duration (Months)

16.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Syndrome	Drug: Dexamethasone Drug: Midazolam injection	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone

Masking:

Double (Participant, Investigator)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: dexamethasone group sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone	Drug: Dexamethasone Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam Other Names: midazolam
Active Comparator: midazolam group sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam	Drug: Midazolam injection intracarpal injection of midazolam and bupivacaine 0.5%

Arm

Intervention/Treatment

Active Comparator: dexamethasone group

sonar guided median nerve hydrodissection by bupivacaine 0.5% and dexamethasone

Drug: Dexamethasone

Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam

Other Names:

midazolam

Active Comparator: midazolam group

sonar guided median nerve hydrodissection by bupivacaine 0.5% and midazolam

Drug: Midazolam injection

intracarpal injection of midazolam and bupivacaine 0.5%

Outcome Measures

Primary Outcome Measures

comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5% [up to 6 months]
use of visual analogue score

Secondary Outcome Measures

Subjective pain assesment [up to 6 months]
BOSTON questionnaire
complications [pain recurrence after 6 months, neurotoxicity immediately after injection]
neurotoxicity, pain recurrence after injection
Nerve electrophysiology [up to 6 months]
sensory nerve conduction , distal motor latency.
nerve sonogram [up to 6 months]
nerve cross sectional area.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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