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

NCT06133712 | Recruiting

• 1 other identifier: 36226/12/22
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel; Dexmedetomidine; Ozone; Dexamethasone

Outcome Measures

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.

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

Secondary Outcomes (3)

• Median motor nerve conduction study(NCS) evaluation

  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

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

• Analgesic requirement

  First 48 hours post injection .

Study Arms (3)

Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Ozone

ACTIVE COMPARATOR

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: Ozone

Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

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.

Also known as: Precedex®

Dexmedetomidine

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.

Also known as: PubChem CID 24823

Ozone

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.

Also known as: Decadron

Dexamethasone

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine

Tanta, El Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Median Neuropathy

Interventions

Dexmedetomidine; Ozone; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxygen; Gases; Inorganic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• MAHMOUD ELGEBALY, MD

  Tanta faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud T Elgebaly, MD

CONTACT

00201092415231; mahmoud.talaat@med.tanta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 15, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)