Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A

Официальное название

Clinical Effect of Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A in Patients With Upper Extremity Complex Regional Pain Syndrome: A Prospective Randomized, Double-blind, and Comparative Clinical Trial

Обзор

Thoracic sympathetic ganglion block is a percutaneous procedure that paralyzes the action of sympathetic nerves transiently by injecting a local anesthetic around the ganglion. It is performed to diagnose and treat sympathetically maintained pain in phantom limb pain or complex reginal pain syndrome patient. The temperature of the affected arm is often lower than that of the opposite side. As a result of the procedure, the patient may experience sympathetic pain relief, such as coldness, stinging, numbness of the upper extremity. If the procedure does not last long, repetitive block or chemical neurolysis or radiofrequency thermocoagulation for the sympathetic ganglion is performed. However, even though in rare cases, chemical neurolysis is known to cause permanent plexus injury radiofrequency thermocoagulation is known to be less successful than chemical neurolysis because it is difficult to identify and stimulate the exact location of the ganglion. Therefore, it is expected that there will be a benefit to the patients if there is a procedure with long-lasting and avoiding injury. Recently, it has been reported that botulinum toxin (BTX) has been successfully used for the treatment of pain disorders. BTX plays a role with blocking the secretion of acetylcholine from the cholinergic nerve endings. Therefore, the use of BTX is expected to prolong the effect of neural blockade because pre-ganglia sympathetic nerves are cholinergic. It is also known that the action of BTX is not permanent and BTX does not exhibit cytotoxicity or neurotoxicity. Therefore, Botulinum toxin type A (BTA) is recommended for the treatment of migraine, myofascial pain syndrome, and neuropathic pain accompanied by allodynia. This study would like show whether thoracic sympathetic ganglion block using BTA has a longer duration than conventional local anesthesia by using prospective randomized, double-blind, parallel group, and comparative clinical trials.

Вмешательства

• Препарат Botulinum toxin A
  Patients were assigned 1:1 to a control group using only local anesthetics (Group A) and a BTX-A group (Group B). In Phase 1, the needle is inserted near the vertebrae T3 under fluoroscopic guidance. An 1 ml of non-ionized contrast medium is injected to evaluate the diffusion pattern, and 3ml of 0.75% ropivacaine is injected. After identifying a temperature increase in the ipsilateral palm within 20 min in the operating room with the prone position, 3 ml of 0.375% ropivacaine and botulinum toxin

Первичные конечные точки

• The changes in average pain intensity in 4weeks [Срок оценки: 4 weeks after procedure]

Вторичные конечные точки (10)

• The changes in average pain intensity in 12weeks [Срок оценки: 12 weeks after procedure]
• The changes in maximum pain intensity [Срок оценки: 4 and 12 weeks after procedure]
• The changes in pain related to procedure [Срок оценки: 30 minutes after the procedure]
• The change in the temperature difference [Срок оценки: 30 minutes, 4 and 12 weeks after the procedure]
• Blood flow velosity [Срок оценки: 30 minutes, 4 and 12 weeks after the procedure]
• Korean CISS (Cold Intolerance Symptom Severity) Questionnaire [Срок оценки: 4 and 12 weeks after the procedure]
• Paindetect questionare (PD-Q) [Срок оценки: 4 and 12 weeks after the procedure]
• Patient satisfaction [Срок оценки: after procedure]
• Medication change (Opioids) [Срок оценки: 4 and 12 weeks after the procedure]
• Additional intervention [Срок оценки: 4 and 12 weeks after the procedure]

Критерии участия

Критерии включения

• aged 19-80 years
• Diagnosed with a complex regional pain syndrome (type 1 or 2) in unilateral upper extremity
• 11-point numerical-rating-scale (NRS) pain score of 4 or higher in upper extremity
• Temperature increase at diagnostic thoracic sympathetic ganglion block
• Patients taking medication stably (without change in dosage/recipe) for more than 4 weeks prior to administration

Критерии исключения

• Refusal of the patient
• Vascular disease at upper extremity
• previous thoracic sympathetic neurolysis (thermocoagulation, chemical neurolysis)
• coagulopathy
• systemic infection or local infection at thoracic puncture site
• significant deformity at thoracic spine
• neoplasm
• known allergic reaction with amide type local anesthetics
• cognitive dysfunction (not understanding of numerical-rating-scale)
• known allergic reaction with botulinum toxin
• pregnant or feeding women
• If the patient has participated in another clinical trial within 30 days before screening, or if passed no longer than 5-fold half-life of the clinical trial drug of the participating clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06470581 · 2402-117-1516

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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