Clinical trial

Comparison Between Cervical Epidural and Stellate Ganglion Block in Management of Complex Regional Pain Syndrome of the Upper Limb A Prospective Comparative Study

Name

36264MD58/3/23

Description

Evaluate the efficacy of two regimens of management in relieving chronic refractory pain in patients with upper limb complex regional pain syndrome after orthopedic trauma

Trial arms

Trial start

2023-08-01

Estimated PCD

2024-06-01

Trial end

2024-06-01

Status

Recruiting

Phase

Early phase I

Treatment

Ultrasound guided Stellate ganglion block

Under visualization with ultrasound, a 22-gauge, 5-cm needle inserted perpendicular to the skin to rest anteriorly to the precervical fascia. 6 mL lidocaine 0.125% and 8 mg dexamethasone in a total volume of 8 mL is used. After injection of a 0.5-mL test dose to exclude intravascular positioning, the remainder of the appropriate dose was administered. The patient will be encouraged to lie flat for 3 minutes after the injection and then to sit up.

Arms:

Ultrasound guided Stellate ganglion block

unilateral cervical epidural

Aseptic betadine skin preparation will be performed and sterile drapes will be applied. Local anesthetic infiltration of the skin at C7-T1 interspace will be done using 2-3 mL of lidocaine 2% with guidance of the C-arm an 18-gauge. Tuohy needle will be inserted at C7-T1 interspace and directed towards either right or left epidural recess according to the site of the operation. Identification of entering the epidural space will be confirmed by hanging drop technique. The position of the needle is the confirmed by injection of 1 mL of non-ionized diluted dye (omnipause 300) to confirm unilateral spread of the dye. After that, a test dose was administrated, consisting of 2 mL of 2% lidocaine with 1:200,000 epinephrine.

Arms:

unilateral cervical epidural

Size

Primary endpoint

The percent on satisfactory relief of pain

6 month post injection

Eligibility criteria

Inclusion Criteria: 1. Patients aged more than 21 years old of both sexes with American Society of Anesthesiologists I and II 2. Upper limb trauma patients with pain disproportionate to the degree of tissue injury and persists beyond the normal expected time for tissue healing 3. Patients diagnosed as (Complex Regional Pain Syndrome ) based on Budapest criteria There should be at least one symptom or sign in three of the four previous categories that can not be explained by other diagnosis. 4. The average daily pain intensity required on Numerical Rating Scale is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy Non-steroidal anti-inflammatory drugs, Antiepileptic drugs(AEDs), antidepressants), as well as physical therapy and psychiatric care. Exclusion Criteria: * Patient refusal * Patients with unstable psychological or psychiatric conditions, including: untreated bipolar disorder, post-traumatic stress disorder, major depression, severe personality disorder and psychotic illness * Patients have recently undergone major interventional pain procedures, such as nerve blocks or implantable therapies. * Patients with known drug dependency or substance use disorder specifically related to ketamine or other psycho-stimulant drugs * Patients with previous severe reactions, contraindication or allergy to ketamine * Patients with hepatic or renal impairment * Active infection at the injection site * Known allergies to medications * Previous neck surgeries * Raynaud's disease or Raynaud's phenomena * Coagulopathy

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-09-05

1 organization

2 products

3 indications

Organization

Tanta University

Product

Ultrasound guided Stellate ganglion block

Indication

Stellate Ganglion Block

Indication

Cervical Epidural

Indication

Complex Regional Pain Syndromes

Product

Unilateral Cervical Epidural