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

Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05344495
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
6.7
Anticipated Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

Condition or Disease Intervention/Treatment Phase
  • Drug: hyalase group
  • Drug: midazolam group
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.
Actual Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
Jul 20, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain score [6 months]

      visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain

    Secondary Outcome Measures

    1. Boston questionnaire [6 months]

      symptom severity ... function severity

    2. median nerve sonogrphy [6 months]

      cross sectional area

    3. Nerve electrophysiology [6 months]

      sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mina Raouf ALMinya Minia Egypt 6115

    Sponsors and Collaborators

    • Minia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mina Maher, Lecturer of anesthesia and ICU, Minia University
    ClinicalTrials.gov Identifier:
    NCT05344495
    Other Study ID Numbers:
    • 277/4-2022
    First Posted:
    Apr 25, 2022
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carpal Tunnel Syndrome
    Neuralgia
    Midazolam
    Bupivacaine

    Study Results

    No Results Posted as of Jun 15, 2022