Dexmedetomidine Versus Triamcinolone Treatment of Carpal Tunnel Syndrome
Primary Purpose
Chronic Pain, Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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
- allergy to utilized drugs
- diabetic
- previous surgery in the site of injection
- previous injection in the targeted site within the last year
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
Secondary Outcome Measures
change of cross sectional area of the median nerve
change of cross sectional area of the median nerve mm2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961281
Brief Title
Dexmedetomidine Versus Triamcinolone Treatment of 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
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
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
Yes
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 modaleties 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
Chronic Pain, 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 (Actual)
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 Dexmedetomidine ( 10 microgram/kg) + 10 cc saline injection nearby median nerve as hydro-dissection
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
injection of triamcinolone ( 40 mg) + 10 cc saline injection nearby median nerve as hydro-dissection
Primary Outcome Measure Information:
Title
pain visual analoge scale
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
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
allergy to utilized drugs
diabetic
previous surgery in the site of injection
previous injection in the targeted site within the last year
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12535461
Citation
O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.
Results Reference
background
PubMed Identifier
26196332
Citation
Li B, Li Y, Tian S, Wang H, Wu H, Zhang A, Gao C. Anti-inflammatory Effects of Perioperative Dexmedetomidine Administered as an Adjunct to General Anesthesia: A Meta-analysis. Sci Rep. 2015 Jul 21;5:12342. doi: 10.1038/srep12342.
Results Reference
background
PubMed Identifier
18719449
Citation
Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.
Results Reference
background
PubMed Identifier
24445644
Citation
Sukegawa S, Higuchi H, Inoue M, Nagatsuka H, Maeda S, Miyawaki T. Locally injected dexmedetomidine inhibits carrageenin-induced inflammatory responses in the injected region. Anesth Analg. 2014 Feb;118(2):473-480. doi: 10.1213/ANE.0000000000000060.
Results Reference
background
PubMed Identifier
26160316
Citation
Honda Y, Higuchi H, Matsuoka Y, Yabuki-Kawase A, Ishii-Maruhama M, Tomoyasu Y, Maeda S, Morimatsu H, Miyawaki T. The inhibitory effect of locally injected dexmedetomidine on carrageenan-induced nociception in rats. Eur J Pharmacol. 2015 Oct 5;764:215-219. doi: 10.1016/j.ejphar.2015.06.054. Epub 2015 Jul 6.
Results Reference
background
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Dexmedetomidine Versus Triamcinolone Treatment of Carpal Tunnel Syndrome
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