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Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome, Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Hyalase
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients
  • complaining of carpal tunnel syndrome of 3 month duration or more
  • diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

  • • patient refusal infection at the site of intervention

    • local anesthetic allergy

Sites / Locations

  • Emad Zarief Kamel SaidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmeditomidine group

Hyalase

Arm Description

injection of 1 microgram/kg dexmedetomidine + 10 cc saline injection nearby median nerve as hydrodissection

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Outcomes

Primary Outcome Measures

Pain alleviation
pain alleviation improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10

Secondary Outcome Measures

Median nerve cross sectional area
Changes in ultrasound imaging change of cross sectional area in cubic mellimeter

Full Information

First Posted
March 6, 2022
Last Updated
August 11, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05280223
Brief Title
Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome
Official Title
Dexmedetomidine Versus Hyalase Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
February 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine upon the median nerve could offer symptoms and clinical improvement
Detailed Description
Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmeditomidine group
Arm Type
Active Comparator
Arm Description
injection of 1 microgram/kg dexmedetomidine + 10 cc saline injection nearby median nerve as hydrodissection
Arm Title
Hyalase
Arm Type
Active Comparator
Arm Description
injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydrodissection
Intervention Type
Drug
Intervention Name(s)
Hyalase
Intervention Description
injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
Primary Outcome Measure Information:
Title
Pain alleviation
Description
pain alleviation improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Median nerve cross sectional area
Description
Changes in ultrasound imaging change of cross sectional area in cubic mellimeter
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients complaining of carpal tunnel syndrome of 3 month duration or more diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study Exclusion Criteria: • patient refusal infection at the site of intervention local anesthetic allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad Zerief Kamel
Phone
+201007046058
Email
emadzarief@aun.eu.eg
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad Z Kamel, M.D.
Phone
+201007046058
Email
emadzarief@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome

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