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

NCT ID: NCT05344495

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-08-01

Brief Summary

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Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

Detailed Description

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Conditions

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Pain, Neuropathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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hyalse group

ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

hyalase group

Intervention Type DRUG

bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.

midazolam group

ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

midazolam group

Intervention Type DRUG

2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%

Interventions

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hyalase group

bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.

Intervention Type DRUG

midazolam group

2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%

Intervention Type DRUG

Other Intervention Names

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Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5% Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mina Raouf

ALMinya, Minya Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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mina raouf

Role: primary

01015752424

Other Identifiers

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277/4-2022

Identifier Type: -

Identifier Source: org_study_id

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