Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Ozone, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel, Dexmedetomidine, Ozone, Dexamethasone. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study Between Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Long- Term Pain Relief
Overview
The aim of the present study is to compare the analgesic efficacy of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome.
Detailed 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.
Interventions
- 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. - Drug Ozone
Participants will receive a single local injection of 4 ml ozone (10 micrograms/ml) plus to 1 ml lidocaine (1%) using a 25 G needle. - Drug 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.
Primary outcome measures
- The analgesic efficacy and functional status improvement of Dexmedetomidine, Ozone and Dexamethasone regional injection in carpal tunnel syndrome [Time frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date]
Secondary outcome measures (3)
- Median motor nerve conduction study(NCS) evaluation [Time frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date]
- Sensory nerve conduction study(NCS) evaluation [Time frame: Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date]
- Analgesic requirement [Time frame: First 48 hours post injection .]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Medicine — Tanta
Identifiers
NCT: NCT06133712 · 36226/12/22