Cervical Epidural and Stellate Ganglion Block in Upper Limb Complex Regional Pain Syndrome

Tanta University

Status and phase: Enrolling; Phase 4

Conditions: Complex Regional Pain Syndromes; Stellate Ganglion Block; Cervical Epidural

Treatments: Drug: unilateral cervical epidural; Drug: Ultrasound guided Stellate ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT05970146

36264MD58/3/23

Details and patient eligibility

About

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

Full description

Ideal therapy for Complex Regional Pain Syndrome is multimodal with the use of physical therapy, psychotherapy, and pharmacologic therapy to complement interventional procedures. Within pharmacotherapy, drugs most often utilized include non steroidal anti-inflammatory drugs (NSAIDs), gamma-aminobutyric acid receptor agonists (i.e., gabapentin, pregabalin), and N-methyl-D-aspartate (NMDA) receptor antagonists (i.e., Ketamine).

In complex Regional Pain Syndrome treatment, stellate ganglion block (SGB) is a well-established method of nerve blockade of the sympathetic ganglia in the lower cervical and upper thoracic region.

Epidural block have differential block as sensory, motor, and sympathetic. Nerve functions are blunt at different rates and to different degrees. Sensory block occurs with a lower concentration of Local anathesia and develops faster than motor block with coexisting sympathectomy.

Enrollment: 90 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Ultrasound guided Stellate ganglion block

Experimental group

Description:

The procedure is going to be the anterior paratracheal approach on the cervical sympathetic chain

Treatment:

Drug: Ultrasound guided Stellate ganglion block

unilateral cervical epidural

Experimental group

Description:

The patient is placed in prone position, with stabilization of the forehead on a padded support

Treatment:

Drug: unilateral cervical epidural