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

Study Overview

• Status: Completed
• Conditions: Pain Syndrome
• Intervention / Treatment: Drug: Dexamethasone; Drug: Midazolam injection

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ALMinya, Egypt, 6115
    • Mina Maher Raouf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing efficacy of midazolam against dexmethasone in combination with bupivacaine 0.5%	use of visual analogue score	up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: median nerve; Midazolam; dexamethasone
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Dexamethasone; Midazolam
• Other Study ID Numbers: 644/4-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No