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
1
2
6.7
15

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:

    Study Results

    No Results Posted as of Jun 15, 2022