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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04961281
Other study ID # IRB0002021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 22, 2021
Est. completion date August 1, 2022

Study information

Verified date October 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 1, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
injection of Dexmedetomidine ( 10 microgram/kg) + 10 cc saline injection nearby median nerve as hydro-dissection
Triamcinolone
injection of triamcinolone ( 40 mg) + 10 cc saline injection nearby median nerve as hydro-dissection

Locations

Country Name City State
Egypt Emad Zarief Kamel Said Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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;(1):CD003219. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain visual analoge scale visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain 6 months
Secondary change of cross sectional area of the median nerve change of cross sectional area of the median nerve mm2 6 months
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