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

NCT05970146 | Unknown Phase 4 DMC

• 1 other identifier: 36264MD58/3/23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Stellate Ganglion Block; Cervical Epidural; Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

• The percent on satisfactory relief of pain

  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.

  6 month post injection

Secondary Outcomes (2)

• The degree of chronic pain using Brief Pain Inventory

  6 month post injection

• The incidence of complication

  2 hours post-intervention

Study Arms (2)

Ultrasound guided Stellate ganglion block

EXPERIMENTAL

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

Drug: Ultrasound guided Stellate ganglion block

unilateral cervical epidural

EXPERIMENTAL

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

Drug: unilateral cervical epidural

Interventions

Ultrasound guided Stellate ganglion block DRUG

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.

Ultrasound guided Stellate ganglion block

unilateral cervical epidural DRUG

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.

unilateral cervical epidural

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged more than 21 years old of both sexes with American Society of Anesthesiologists I and II
• Upper limb trauma patients with pain disproportionate to the degree of tissue injury and persists beyond the normal expected time for tissue healing
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, Egypt

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 1, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

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

Locations

EG (1)