Back to results

Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine

Triamcinolone

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

20 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 allergy to utilized drugs diabetic previous surgery in the site of injection previous injection in the targeted site within the last year

Sites / Locations

Assiut Universit HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Dexmeditomidine group

Triamcinolone group

Arm Description

injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection

injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection

Outcomes

Primary Outcome Measures

pain visual analoge scale visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary Outcome Measures

change of cross sectional area of the median nerve

change of cross sectional area of the median nerve mm2

Full Information

NCT ID

NCT05624866

First Posted

October 31, 2022

Last Updated

November 14, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05624866

Brief Title

Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome

Official Title

Dexmedetomidine Versus Triamcinolone Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 10, 2022 (Actual)

Primary Completion Date

June 10, 2023 (Anticipated)

Study Completion Date

July 10, 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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modalities are available for treatment of mild to moderate CTS.

Detailed Description

Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS. In case of failed conservative oral therapey, local hydro-dessction of the median nerve can be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized to augment the symptoms reliefe. Dexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects when injected in the perineural area. Upon such discovery, the goal of this study has been built.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment Investigate if, and to what extent,carapl tunnel hydro-dissection using DEX or triamcinolone (TM) along with saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.

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

Arm Title

Triamcinolone group

Arm Type

Active Comparator

Arm Description

injection of 40 mg triamcinolone + 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 hydro-dissection

Intervention Type

Drug

Intervention Name(s)

Triamcinolone

Intervention Description

injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection

Primary Outcome Measure Information:

Title

pain visual analoge scale visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Description

visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Time Frame

6 months

Secondary Outcome Measure Information:

Title

change of cross sectional area of the median nerve

Description

change of cross sectional area of the median nerve mm2

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Assiut Universit Hospital

City

Assiut

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emad Said, Professor

Phone

01007046058

emadzarief@aun.edu.eg

First Name & Middle Initial & Last Name & Degree

Rafeek Aziz, Assistant lecturer

Phone

01006018620

rafeek_aziz@med.aun.du.eg

12. IPD Sharing Statement

Learn more about this trial

Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome

We'll reach out to this number within 24 hrs