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

Phase 4

Recruiting

• Conditions: Stellate Ganglion Block; Complex Regional Pain Syndromes; Cervical Epidural
• Interventions: Drug: Ultrasound guided Stellate ganglion block; Drug: unilateral cervical epidural

• Registration Number: NCT05970146
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-30
• Status Verified: 2023-08
• Study Start: 2023-08-01
• Study First Posted: 2023-08-01
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided Stellate ganglion block	Ultrasound guided Stellate ganglion block	The procedure is going to be the anterior paratracheal approach on the cervical sympathetic chain
unilateral cervical epidural	unilateral cervical epidural	The patient is placed in prone position, with stabilization of the forehead on a padded support

Primary Outcome Measures

Name	Time	Method
The percent on satisfactory relief of pain	6 month post injection	Numerical rating scales (NRS) is an 11-Point Scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable.; NRS was measured before, immediately after injection, 3 and 6 month post injection.

Secondary Outcome Measures

Name	Time	Method
The degree of chronic pain using Brief Pain Inventory	6 month post injection	Brief Pain Inventory short form (BPI-SF) questionnaire. It is a nine item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, normal work, relations with other persons, sleep, and enjoyment of life on a 10 Point Scale; BPI-SF was measured before, immediately after injection, 3 and 6 month post injection
The incidence of complication	2 hours post-intervention	complications as hypotension, headache and neck pain

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt