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临床试验/NCT03942796
NCT03942796已完成不适用

Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1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
30
试验地点
1
主要终点
Change in the severity of pain

研究概览

简要总结

Chronic Post thoracotomy pain syndrome (PTPS) is defined PTPS as pain that develops or increases in intensity after a thoracotomy and persists beyond the healing process, that's to say at least 3 months after the initiating event. The pain has to be localized to the site of incision or, projected to the innervation territory of a nerve situated in this area or referred to a dermatome or Head's zone (after surgery/injury to deep somatic and visceral tissues The incidence of PTPS is 57% and 47% of patients at 3 and 6 months after thoracotomy, respectively.

Management of PTPS begins with prevention. Preventive strategies are based on multimodal preemptive and intraoperative analgesia. Treatment of PTPS is either pharmacologic treatment which is systematically initiated by first line drugs including tricyclic anti-depressants (TCA), serotonin-norepinephrine reuptake inhibitors (SNRI), gabapentinoids. Second-line treatments include topical lidocaine, capsaicin, and weak opioid analgesics (tramadol). Third line treatments consist of strong opioids (oxycodone, morphine) and subcutaneous botilinium toxin injection.

Other therapies for management of CPTP include such modalities as transcutaneous electrical nerve stimulation (TENS), Spinal cord and peripheral nerve stimulation, acupuncture and neurolysis using pulsed radiofrequency for intercostal nerve or dorsal root ganglio and cryoneurolysis for intercostal nerve. The mode of action of pulsed RF is not well-understood, but may include inhibition of excitatory C-fiber responses by repetitive, burst-like stimulation of A-delta fibers, global reduction of evoked synaptic activity and minor structural changes in nerve tissue; elicited by alterations in the function of the blood-nerve barrier, fibroblast activation and collagen deposition.

详细描述

The aim of the work is to evaluate the effect of oral pregabalin and pulsed radiofrequency ablation (PRF) ablation of the dorsal root ganglion (DRG) in the treatment of chronic post thoracotomy pain syndrome, using Visual Analogue Scale (VAS) score.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status III or IV
  • Persistent pain score ≥ 5 on VAS for 3 months or more, not responding to traditional OTC analgesics

排除标准

  • Patient refusal
  • The presence of pathology that could account for a majority of persistent symptoms (e.g. recurrent cancer)
  • coagulopathy
  • Uncooperative patients

研究组 & 干预措施

lyrica, vronogabic (pregabalin)

Active Comparator

Patients would receive oral pregabalin

干预措施: lyrica, vronogabic (pregabalin) (Drug)

结局指标

主要结局

Change in the severity of pain

时间窗: day 1, 3 months

measured by 11 point VAS score from 0 to 10. the patient is asked to report the severity of his pain in which 0 represents no pain and 10 is the maximum pain. VAS below 5 is considered a "successful" outcome of the treatment method and VAS score ≥ 5 is considered a "failure" outcome. In case of a "failure" outcome, patients will be given oral acetaminophen 500 mg every 8 hours and/or oral ibuprofen 400 mg every 8-12 hours and the need for rescue analgesia will be recorded. is measured by 11 point VAS score from 0 to 10. the patient is asked to report the severity of his pain in which 0 represents no pain and 10 is the maximum pain. VAS below 5 is considered a "success" outcome of the treatment method and VAS score ≥ 5 is considered a "failure" outcome. In case of a "failure" outcome, patients will be given oral acetaminophen 500 mg every 8 hours and/or oral ibuprofen 400 mg every 8-12 hours and the need for rescue analgesia will be recorded.

次要结局

  • the number of patients who developed somnolence as a side effect of treatment(immediately after the intervention, 2weeks, 1, 2, 3 months)
  • The number of patients who developed nausea as a side effect of treatment(immediately after the intervention, 2weeks, 1, 2, 3 months)
  • the number of patients who needed rescue analgesia(2weeks, 1, 2, 3 months)
  • the number of patients who developed dizziness as a side effect of treatment(immediately after the intervention, 2weeks, 1, 2, 3 months)
  • The number of patients who developed imbalance as a side effect of treatment(immediately after the intervention, 2weeks, 1, 2, 3 months)
  • The number of patients who developed constipation as a side effect of treatment(immediately after the intervention, 2weeks, 1, 2, 3 months)
  • The number of patients who developed pneumothorax as a side effect of treatment(immediately after the intervention, 2weeks, 1, 2, 3 months)
  • Patient satisfaction(2weeks, 1, 2, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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