Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief

Dexmedetomidine Clinical Trial

Official title:

A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133712
• Other study ID #: 36226/12/22
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: Mahmoud T Elgebaly, MD
• Phone: 00201092415231
• Email: mahmoud.talaat[@]med.tanta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.

Description:

Carpal tunnel syndrome (CTS) is a collection of symptoms and signs associated with median neuropathy at the carpal tunnel. Most CTS is related to idiopathic compression of the median nerve as it travels through the wrist at the carpal tunnel. Corticosteroid injection is an extensively used and accepted treatment in mild to moderate CTS according to the guidelines of the American Academy of Orthopedic Surgeons as corticosteroids reduce the inflammation and edema associated with CTS. However, there is no guideline as to which corticosteroid has to be used as the standard treatment in CTS. Triamcinolone acetonide, a commonly used steroid for this indication, is a particulate steroid, which can cause permanent nerve injury if accidentally injected into the nerve. Local ozone injection as a therapeutic option in some musculoskeletal conditions; ozone (O3) gas is a molecule consisting of three oxygen atoms in a dynamically unstable structure. Ozone therapy has been utilized and studied for more than a century.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age from 20 to 60 years.
• Both sexes.
• Patients with ultrasonographic evidence of mild-to-moderate carpal tunnel syndrome (CTS).
• Inclusion criteria will include numbness and pain in the median nerve (MN) distribution persisting for minimum of 3 months , nerve conduction studies (NCS) consistent with carpal tunnel syndrome (CTS) as per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines, and an median nerve (MN) cross-sectional area (CSA)at the wrist >12 mm2 suggesting mild-to-moderate CTS forms.

Exclusion Criteria:

• Patient refusal.
• Patients with severe symptoms and signs of CTS as identified per the American Association of Neuromuscular and Electro diagnostic Medicine (AANEM) guidelines,[14] as this is an indication for surgery,
• Patients who show improvement on medical treatment,
• Previous surgical or injectional CTS treatment,
• Pregnancy ,co existence of brachial plexopathy, or thoracic outlet syndrome, polyneuropathy, radiculopathy and peripheral nerve lesion in upper limb.
• Severe cardiovascular disease
• Morbid obese patients (body mass index (BMI) of >35 kg/m2)
• Infection at site of injection.
• Bleeding diathesis.
• History of thyroid deficiency, uncontrolled diabetes mellitus , rheumatoid arthritis and history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
• History of Ozone or Dexmedetomidine allergy.
• End stage renal and hepatic disease.
• History of inflammatory joint , connective tissue disorders, , burns, any local tissue contractures and history of wrist trauma.
• Patients who will not consent to completing The visual analogue scale (VAS) for pain or nerve conduction study before and after injection.

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome
• Dexamethasone
• Dexmedetomidine
• Ozone

Intervention

Drug:
• Dexmedetomidine
Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve.
• Ozone
Participants will receive a single local injection of 4 ml ozone (10 micrograms/dl) plus to 1 ml lidocaine (1%) using a 25 G needle.
• Dexamethasone
Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL [8 mg] dexamethasone) via the same technique.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Tanta	El Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome	The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome via assessment of Visual Analogue Scale (VAS) before and after injection.; VAS used as an effective tool to detect intensity of pain will be recorded (0 to10) "0" represents no pain ,"10" worst pain, "1-3" mild pain,"4-6 " moderate pain and" 7-10 " severe pain.; Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24 weeks intervals after injection.	Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Secondary	Median motor nerve conduction study(NCS) evaluation	Each patient will be assessed regarding electrophysiological changes sensory nerve conduction velocity in millimeter/seconds and distal motor latency in milliseconds at the baseline (before injection), at 1week, 4weeks, 12 weeks and 24 weeks intervals after injection.	Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Secondary	Sensory nerve conduction study(NCS) evaluation	Each patient will be assessed regarding electrophysiological changes sensory nerve conduction velocity in millimeter/seconds and distal motor latency in milliseconds at the baseline (before injection), at 1week, 4weeks, 12weeks, and 24 weeks intervals after injection.	Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date
Secondary	Analgesic requirement	Analgesic requirement ( dose and frequency of oral acetaminophen intake in first 48 hours) for post injection .	First 48 hours post injection .