Complex Regional Pain Syndromes Clinical Trial
Official title:
Comparison Between Cervical Epidural and Stellate Ganglion Block in Management of Complex Regional Pain Syndrome of the Upper Limb A Prospective Comparative Study
Verified date | August 2023 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | El-Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The degree of chronic pain using Brief Pain Inventory | 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 |
6 month post injection | |
Secondary | The incidence of complication | complications as hypotension, headache and neck pain | 2 hours post-intervention |
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