Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management
Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management: A Randomized Controlled Trial
Cancer breast is one of the most common tumors among women and surgery is still the key for its management and cure. Post-mastectomy pain control is crucial as acute postoperative pain is a significant factor in the development of persistent chronic pain in the form of post-mastectomy pain syndrome.
Post-mastectomy pain syndrome (PMPS) is a common complication after breast cancer surgery and is often challenging to manage. It is estimated that PMPS occurs in 20%-44% of patients after breast surgery.
Adequate pain control for PMPS has become one of the most important goals and recently can achieve by multiple tools including multimodal analgesia and regional techniques.
Erector spinae block (ESB) is one of the new described regional techniques. Although its mechanism is not clear, the published data agree that it is promising block for chronic and acute pain and its simplicity and safety compared with thoracic epidural or bilateral paravertebral blocks.
ESB can be performed using a superficial approach between the large rhomboid muscle and the erector spinae muscle or the deep method beneath the erector spinae.
The use of the ESPB for chronic pain has recently expanded for various neuropathic pain conditions. Also, it reported with several volumes range from 10 to 30 ml of total volume.
研究概览
详细说明
This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study.
Patients more than 18 years old of both genders with PMPS not responding to medical treatments, and numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain)., American society of Anesthesiology Physical Status class I and II, and Body mass index ˂ 30 were included in this study.
The exclusion criteria are patient refusal, local or systemic sepsis, coagulopathy, unstable cardiovascular and respiratory diseases, previous neurological deficits, history of psychiatric disorders, history of drug abuse, distorted local anatomy, and those who were allergic to the used medications were excluded from the study.
All the patients will inform about the numerical rating score (NRS) from zero to 10 (where 0 no pain, 10 the worst pain) to describe their pain.
Random selection of patients:
The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block.
Grouping:
Group A: receive ESR with 1mL of methylprednisolone 40mg/mL with 10 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 7 ml saline 0.9% (total 20 ml with bupivacaine 0.25%).
Group B: receive ESR with 1mL of methylprednisolone 40mg/mL with 15 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 12 ml saline 0.9% (total 30 ml with bupivacaine 0.25%).
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：yahya m wahba, assist professor
- 电话号码：01211313554
- 邮箱：yahyawahba@ymail.com
研究联系人备份
- 姓名：ghada F Amer
- 电话号码：01008081333
- 邮箱：ghadafouad2018@gmail.com
学习地点
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Mansoura、埃及
- 招聘中
- Nevert adel
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接触：
- Yahya M Wahba, MD
- 电话号码：+201211313554
- 邮箱：yahyawahba@ymail.com
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接触：
- ghada F Amer, ass. prof.
- 电话号码：01008081333
- 邮箱：ghadafouad2018@gmail.com
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副研究员：
- ghada F Amer, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients more than 18 years old of both genders
- with post-mastectomy pain syndrome not responding to medical treatments,
- and numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
- American society of Anesthesiology Physical Status class I and II,
- and Body mass index ˂ 30 were included in this study
Exclusion Criteria:
- patient refusal,
- local or systemic sepsis,
- coagulopathy,
- unstable cardiovascular
- and respiratory diseases,
- previous neurological deficits,
- history of psychiatric disorders,
- history of drug abuse,
- distorted local anatomy,
- and those who were allergic to the used medications
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Group 20 ml
receive ESB with 1mL of methylprednisolone 40mg/mL with 10 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 7 ml saline 0.9% (total 20 ml with bupivacaine 0.25%).
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The patients will do the procedure under fluoroscopic guidance.
The patients were placed in prone position.
After the identification of the T4 transverse process, the targeted injection site was anesthetized with 3-4 ml of 2% lidocaine.
A 25-gauge spinal needle was advanced until it contacted the transverse process at the T4 level.
Next, a solution of 1mL of methylprednisolone 40mg/mL with 7 mL of 0.25% bupivacaine and 2mL of nonionic contrast in 10 ml saline 0.9% (group A) and in 20 ml saline 0.9% (group B) will injected.
Then another photo will be taken with the fluoroscopy to determine the level of spread in each group.
After finished, the patients will transfer to the post-operative care unit and will monitored for any complication for one hour.
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有源比较器：Group 30 ml
receive ESB with 1mL of methylprednisolone 40mg/mL with 15 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 12 ml saline 0.9% (total 30 ml with bupivacaine 0.25%).
|
The patients will do the procedure under fluoroscopic guidance.
The patients were placed in prone position.
After the identification of the T4 transverse process, the targeted injection site was anesthetized with 3-4 ml of 2% lidocaine.
A 25-gauge spinal needle was advanced until it contacted the transverse process at the T4 level.
Next, a solution of 1mL of methylprednisolone 40mg/mL with 7 mL of 0.25% bupivacaine and 2mL of nonionic contrast in 10 ml saline 0.9% (group A) and in 20 ml saline 0.9% (group B) will injected.
Then another photo will be taken with the fluoroscopy to determine the level of spread in each group.
After finished, the patients will transfer to the post-operative care unit and will monitored for any complication for one hour.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The level spread of each volume.
大体时间：immediately after injection. C arm photo will be taken to know the level of distribution
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The level spread of each volume.
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immediately after injection. C arm photo will be taken to know the level of distribution
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Numerical analogue scale
大体时间：after 4 weeks from procedure
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from 0 (no pain) to 10 (sever pain)
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after 4 weeks from procedure
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Numerical analogue scale
大体时间：after 8 weeks from procedure
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from 0 (no pain) to 10 (sever pain)
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after 8 weeks from procedure
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Numerical analogue scale
大体时间：after 12 weeks from procedure
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from 0 (no pain) to 10 (sever pain)
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after 12 weeks from procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient satisfaction
大体时间：after 4 weeks from the procedure
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evaluated by using a linear scale in which 0 is very dissatisfied and 10 is very satisfied.
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after 4 weeks from the procedure
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- R.21.11.1523
药物和器械信息、研究文件
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erector spinae block的临床试验
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Queen Mary University of LondonNational Health Service, United Kingdom未知
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