Comparison Between Cervical Epidural and Stellate Ganglion Block in Management of Complex Regional Pain Syndrome of the Upper Limb A Prospective Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The percent on satisfactory relief of pain
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Ultrasound guided Stellate ganglion block
The procedure is going to be the anterior paratracheal approach on the cervical sympathetic chain
干预措施: Ultrasound guided Stellate ganglion block (Drug)
unilateral cervical epidural
The patient is placed in prone position, with stabilization of the forehead on a padded support
干预措施: unilateral cervical epidural (Drug)
结局指标
主要结局
The percent on satisfactory relief of pain
时间窗: 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.
次要结局
- The degree of chronic pain using Brief Pain Inventory(6 month post injection)
- The incidence of complication(2 hours post-intervention)
研究者
Aya Hassan Moustafa Hegazy
Assistant lecturer
Tanta University