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

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

NCT ID: NCT05970146

Condition: Stellate Ganglion Block
Cervical Epidural
Complex Regional Pain Syndromes

Conditions: Official terms:
Ganglion Cysts
Synovial Cyst
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Ultrasound guided Stellate ganglion block
Description: 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.
Arm group label: Ultrasound guided Stellate ganglion block

Intervention type: Drug
Intervention name: unilateral cervical epidural
Description: 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.
Arm group label: unilateral cervical epidural

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.

Criteria for 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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Tanta University

Address:
City: Tanta
Country: Egypt

Status: Recruiting

Contact:
Last name: Aya H Hegazy

Phone: +20 101 192 3265
Email: Ahhegazy1993@gmail.com

Start date: August 1, 2023

Completion date: June 1, 2024

Lead sponsor:
Agency: Tanta University
Agency class: Other

Source: Tanta University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05970146