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

NCT ID: NCT06133712

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Conditions

Carpal Tunnel; Dexmedetomidine; Ozone; Dexamethasone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Ozone

Intervention Type: 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

Patients will receive a single local injection of 5 mL (3 mL lidocaine (1%) and 2 mL \[8 mg\] dexamethasone) via the same technique.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: 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.

Interventions

Dexmedetomidine

Patients will receive injection of 1 microgram/kg dexmedetomidine average (70-100-microgram) (0.7-1ml) plus 4ml lidocaine injection nearby median nerve.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Precedex®; PubChem CID 24823; Decadron

Eligibility Criteria

Inclusion Criteria

• Age from 20 to 60 years.
• Both sexes.
• Patients with ultrasonographic evidence of mild-to-moderate carpal tunnel syndrome (CTS).

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud T Elgebaly,MD

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MAHMOUD ELGEBALY, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta faculty of medicine

Locations

Faculty of Medicine

Tanta, El Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud T Elgebaly, MD

Role: CONTACT

mahmoud.talaat@med.tanta.edu

00201092415231

Facility Contacts

Mahmoud Elgebaly, MD

Role: primary

mahmoud.talaat@med.tanta.edu

00201092415231

Mahmoud Elgebaly, MD

Role: backup

mahmoudelgebaly75@gmail.com

00201006145708

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

36226/12/22

Identifier Type: -

Identifier Source: org_study_id