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临床试验/NCT03494426
NCT03494426已完成不适用

Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study

Assiut University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
The intensity of pain

研究概览

简要总结

Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment for breast cancer, The antineuropathic medications (antidepressants and anticonvulsants) are disappointing and have low success rate. Continues Radiofrequency lesioning has been reported as treatment for several chronic pain conditions.The concept that the clinical effect of RF was caused by formation of heat had not been challenged. Thermocoagulation of nerve fibers would interfere with the conduction of nociceptive stimuli and pain would be relived. Thoracic sympathectomy has been done for many painful conditions that includes complex regional pain syndrome .It offers the benefit over stellate ganglion block as it blocks the Kuntz fibers that connect to the brachial plexus roots without passing through stellate ganglion.

详细描述

Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment for breast cancer including radical mastectomy, modified radical mastectomy,and segmental mastectomy (lumpectomy) . The pain is distributed in the anterior chest, axilla, and medial and posterior parts of the arm . This pain can be sufficiently severe enough to interfere with sleep and performance of daily activities.

Patients may develop an immobilized arm, which can lead to severe lymph edema, frozen shoulder syndrome, and complex regional pain syndrome. PMPS can result from surgical damage to the intercostobrachial nerve( the lateral cutaneous branch of the second intercostal nerve) that is often resected at mastectomy .

The etiology of persistent pain after mastectomy is unclear, although it is likely multifactorial and may be partially neuropathic in nature . Previous reports of PMPS have suggested a limited number of potential risk factors, which are inconsistent among studies . While surgical factors, including more extensive surgery (mastectomy), axillary lymphnode dissection, and reconstruction have been postulated as important risk factors for chronic pain, many studies do not support this association. Adjuvant treatment, such as radiation, chemotherapy, and hormonal therapy, has also been occasionally associated with persistent pain .

Among demographic factors, younger age correlates with increased incidence of persistent pain in some studies but not others .

The antineuropathic medications (antidepressants and anticonvulsants) are disappointing and have low success rate, also have multiple drawbacks , specifically excessive sedation that affects daily life activities of those patients .

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
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients with chronic post-mastectomy pain for at least 6 month post-operative
  • Patients with VAS ≥ 5
  • Patients on pregabalin dose ≥ 150 mg daily
  • Patients treated with more than one line of anti-neuropathic drugs [e.g. pregabalin+(tricyclic antidepressants or selective serotonin reuptake inhibitors ) or pregabalin+ tramadole]
  • Lymphedema of the upper limb

排除标准

  • Patient refusal
  • Coagulopathy
  • Chest and back deformity hindering procedure impossible
  • Infection at the introduction site of the needle

研究组 & 干预措施

interventional group

Experimental

patients will receive Radiofrequency thoracic sympathectomy then will receive pregabalin ,tramadol,and tricyclic antidepressants

干预措施: radiofrequency thoracic sympathectomy (Procedure)

interventional group

Experimental

patients will receive Radiofrequency thoracic sympathectomy then will receive pregabalin ,tramadol,and tricyclic antidepressants

干预措施: pregabalin ,tramadol,and tricyclic antidepressants (Drug)

control group

Active Comparator

patients will receive pregabalin ,tramadol,and tricyclic antidepressants

干预措施: pregabalin ,tramadol,and tricyclic antidepressants (Drug)

结局指标

主要结局

The intensity of pain

时间窗: up to 3 months after the procedure

The intensity of pain measured by visual analogue score

次要结局

  • The changes in analgesics consumption(1 month, 2 month and 3 month post-procedure)
  • The changes in mid-arm circumference(1 month post- procedure)
  • The changes in post-menopausal hot flashes if it was a pre-procedure complaint(3 month post- procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Madona M.NOMAN

doctor

Assiut University

研究点 (1)

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