About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

Dexmedetomidine
Drug
Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve.
Ozone
Drug
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.
Dexamethasone
Drug
Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL \[8 mg\] dexamethasone) via the same technique.

Treatment groups

135 Participants

are divided into 3 treatment groups

Group A: DexmedetomidineActive comparator 1 intervention

Group B: OzoneActive comparator 1 intervention

Group C: DexamethasoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date

Secondary outcomes

1

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.

Time frame

Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date

2

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.

Time frame

Each patient will be assessed at the baseline (before injection) , at 1week, 4weeks, 12weeks, and 24weeks intervals after injection date

3

Analgesic requirement

Analgesic requirement ( dose and frequency of oral acetaminophen intake in first 48 hours) for post injection .

Time frame

First 48 hours post injection .

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts