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

Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527770
• Other study ID #: 644/4-2020
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Pain Syndrome
• Syndrome

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