Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome:

Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.

Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

Study Overview

• Status: Recruiting
• Conditions: Pain, Neuropathic
• Intervention / Treatment: Drug: hyalase group; Drug: midazolam group

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Minia
    • ALMinya, Minia, Egypt, 6115
      • Recruiting
      • Mina 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:

• adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months .

Exclusion Criteria:

• Diabetic patients
• Pregnant population .
• Refusal to participate

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: hyalse group; ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5%	Drug: hyalase group; bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.; Other Names: Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%
Active Comparator: midazolam group; ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5%	Drug: midazolam group; 2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%; Other Names: Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score	visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston questionnaire	symptom severity ... function severity	6 months
median nerve sonogrphy	cross sectional area	6 months
Nerve electrophysiology	sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest	6 months

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): July 20, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Midazolam; Bupivacaine
• Other Study ID Numbers: 277/4-2022

Drug and device information, study documents

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