Dexmedetomidine Clinical Trial
Official title:
A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief
The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Tanta | El Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
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 . |
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