Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The level spread of each volume.
研究概览
简要总结
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.
详细描述
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:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The level spread of each volume.
时间窗: immediately after injection. C arm photo will be taken to know the level of distribution
The level spread of each volume.
Numerical analogue scale
时间窗: after 12 weeks from procedure
from 0 (no pain) to 10 (sever pain)
次要结局
- Patient satisfaction(after 4 weeks from the procedure)
研究者
Nevert Adel
assist. prof. of anesthesia and pain management
Mansoura University