The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 1. Pain score (NRS)
研究概览
简要总结
Erector spinae plane block is new interfascial plane block, and can be applied to management of thoracic neuropathic pain syndromes. The target of needle is deeper(or anterior) to the erector spinae muscle. So it is more safe and simple technique than prior technique, thoracic paravertebral block. The aim of this study is the evaluation of erector spinae plane block comparison to prevertebra block.
详细描述
This study is single-blind because it is not possible to blind the practitioner performing the injection.
Subjects were randomly assigned to the erector spinae plane block group (group E) and the thoracic paravertebral block group (group P) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
Before the procedure, a resident who does not know of this study records the patient's pain and painDETECT. and on follow-up four weeks visits, PGIC scale is checked.
The erector spinae plane block or thoracic paravertebral block should be performed after receiving the informed consent of the patient.
Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
- The subjects were randomly assigned to erector spinae plane block group (group E) and thoracic paravertebral block group (group P), and the assigned results are unknown.
- The Outcomes Assessor is not related to the study, and does not know its contents.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were patients who had chest wall post herpetic neuralgia, with moderate and severe pain and received appropriate antiviral therapy.
排除标准
- •Patient refusal
- •Patients who did not receive appropriate antiviral therapy
- •Patients with mild pain
- •Heavy skin eruption (no healthy area for needle entry) and infection at site of injection.
- •Patients with history of renal, hepatic diseases, coagulopathy, diabetes
- •Patients taking chemotherapy and/or radiotherapy
- •Patients with history of steroid therapy
- •Patients taking narcotic analgesics
- •Patient who does not understand the study because of illiteracy or language problems.
- •Abnormal findings in peripheral blood test (CBC, ESR, CRP, PT/aPTT)
研究组 & 干预措施
erector spinae plane block group (group E)
ultrasound-guided erector spinae plane block
干预措施: erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg) (Procedure)
thoracic paravertebral block group (group P)
ultrasound-guided thoracic paravertebral block
干预措施: thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg) (Procedure)
结局指标
主要结局
1. Pain score (NRS)
时间窗: Changes of Pain score from the procedure to 4 weeks
1. in both groups, the patient is asked to score the pain before the procedure and 4 weeks later. And then the change of pain score is recorded. * NRS(numeric rating scale, on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable)
3. PGIC, 7 scales(overall improvement of pain relief)
时间窗: Changes of PGIC, 7 scales from the procedure to 4 weeks
3. the patient is asked to PGIC, 7 scales about overall improvement of pain relief 4 weeks later. * Patient's global impression of change(PGIC) scale. Since beginning treatment at this clinic, the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition. (No change =1, almost the same = 2, a little better = 3, somewhat better =4, moderate better =5, better =6, a great deal better =7)
2. painDETECT score
时间窗: Changes of painDETECT score from the procedure to 4 weeks
2. the patient is asked to painDETECT score the pain before the procedure and 4 weeks later. And then the change of painDETECT score is recorded. * painDETECT Questionnaire. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. Question 7 asks about radiating pain, answered as yes or no, and scored as 2 or 0 respectively. The total score summed each subscales is between -1 and 38, indicates the likelihood of a neuropathic pain component. A score less than 12 indicates that pain is unlikely to have a neuropathic component, while a score more than 19 suggests that pain is likely to have a neuropathic component.
次要结局
未报告次要终点