Dexmedetomidine Versus Triamcinolone Treatment of Carpal Tunnel Syndrome

NCT04961281 | Completed DMC

• 1 other identifier: IRB0002021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (1)

• change of cross sectional area of the median nerve

  6 months

Study Arms (2)

Dexmeditomidine group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

triamcinolone group

ACTIVE COMPARATOR

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

Drug: Triamcinolone

Interventions

Dexmedetomidine DRUG

injection of Dexmedetomidine ( 10 microgram/kg) + 10 cc saline injection nearby median nerve as hydro-dissection

Dexmeditomidine group

Triamcinolone DRUG

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

triamcinolone group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

Related Publications (5)

• 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.

  PMID: 12535461 BACKGROUND

• 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.

  PMID: 26196332 BACKGROUND

• 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.

  PMID: 18719449 BACKGROUND

• 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.

  PMID: 24445644 BACKGROUND

• 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.

  PMID: 26160316 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Carpal Tunnel Syndrome

Interventions

Dexmedetomidine; Triamcinolone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 14, 2021
• Study Start: July 22, 2021
• Primary Completion: July 31, 2022
• Study Completion: August 1, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)