Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05624866
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 6.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Drug: Dexmedetomidine; Drug: Triamcinolone	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dexmedetomidine Versus Triamcinolone Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial.
• Actual Study Start Date: Oct 10, 2022
• Anticipated Primary Completion Date: Jun 10, 2023
• Anticipated Study Completion Date: Jul 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmeditomidine group injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection	Drug: Dexmedetomidine; injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection
Active Comparator: Triamcinolone group injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection	Drug: Triamcinolone; injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection

Outcome Measures

Primary Outcome Measures

1. pain visual analoge scale visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain [6 months]

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

Secondary Outcome Measures

1. change of cross sectional area of the median nerve [6 months]

   change of cross sectional area of the median nerve mm2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Universit Hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emad Zarief , MD, Professor, Assiut University
• ClinicalTrials.gov Identifier: NCT05624866
• Other Study ID Numbers: 17200681
• First Posted: Nov 22, 2022
• Last Update Posted: Nov 22, 2022
• Last Verified: Nov 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; Syndrome; Triamcinolone; Dexmedetomidine

Study Results

No Results Posted as of Nov 22, 2022