Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Postoperative Pain Control in Patients Undergoing Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total amount of rescue pain medication required within the first 48 hours after surgery
研究概览
简要总结
This study compares two methods of local pain control in patients undergoing Modified Radical Mastectomy, a common surgery for breast cancer( tumor in the breast) treatment. It aims to determine which method, the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block, provides better pain relief after surgery, reduces side effects, and increases patient satisfaction.
Why This Study Is Important:
Breast cancer surgery can cause significant pain, and managing this pain is important for a quick recovery. Currently, pain is often managed with opioids, which can cause side effects like nausea and drowsiness. invistigators want to find a method that controls pain effectively with fewer side effects, helping patients recover faster and feel better.
Who Can Take Part:
Women aged 21 and older who are scheduled for a Modified Radical Mastectomy at Ain Shams University hospitals can participate in this study.
What Will Happen During the Study:
Participants will be randomly assigned to receive either the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block before surgery.
Pain levels will be measured using a numerical pain score from 1 to 10. Researchers will track the amount of pain medication needed, the time it takes to feel pain relief, and any side effects.
Other factors such as sleep quality, time to start walking again, and overall satisfaction with pain control will also be recorded.
What investigators hope to Learn:
Investigators hope to find out which nerve block provides better pain relief after surgery. By comparing TIPB and ESPB, with the aim to identify the method that:
Requires less additional pain medication Has fewer side effects Improves sleep quality and overall recovery Increases patient satisfaction
Significance:
This study could lead to better pain management strategies for breast cancer surgery, reducing the need for opioids and enhancing patient recovery and comfort.
Participation:
Participants will be monitored closely during and after the procedure to ensure their safety and well-being. The results of this study could help improve pain management for future patients undergoing similar surgeries.
详细描述
This study is a randomized, double-blinded clinical trial comparing the efficacy of two ultrasound-guided nerve blocks for postoperative pain management in patients undergoing Modified Radical Mastectomy (MRM). The two techniques under investigation are the Thoracic Interfascial Plane Block (TIPB) and the Erector Spinae Plane Block (ESPB). Both nerve blocks are administered to provide targeted pain relief by numbing specific nerves involved in the surgical area.
Methodology:
Participants will be randomly assigned to one of two groups to receive either TIPB or ESPB. The randomization will ensure unbiased distribution of participants across both groups. The nerve blocks will be administered preoperatively under ultrasound guidance to ensure accurate placement and effectiveness.
Assessments and Measurements:
Pain levels will be assessed using the Visual Analog Scale (VAS) at multiple time points postoperatively, including at rest and during movement. The primary outcome measure is the total amount of rescue pain medication required within the first 48 hours after surgery. Secondary outcomes include the time to first rescue analgesic, intraoperative fentanyl consumption, hemodynamic parameters, sleep quality, time to first ambulation, VAS scores for pain and nausea, and overall patient satisfaction.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All clinical staff, including surgeons, and anesthetists except the one giving the block, nurses, investigators, and patients will be blinded to the treatment group assignment
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients older than 21 years old
- •American Society of Anesthesiologists (ASA) physical status II.
排除标准
- •Known allergy to one of the study's medications.
- •Skin infections at the site of the needle puncture.
- •Significant organ dysfunction (hepatic, renal, or cardiac dysfunction), coagulopathy or recent anticoagulant use, epilepsy.
- •Patients diagnosed with obstructive sleep apnoea, pulmonary compromise .
结局指标
主要结局
Total amount of rescue pain medication required within the first 48 hours after surgery
时间窗: 48 hours
Researchers will report the total amount of analgesia used in the first 48 hours after surgery
次要结局
- Sleep quality(48 hours)
- Time for the first ambulation(48 hours)
- Time to first rescue analgesia'(48 hours)
- Total intraoperative fentanyl consumption(Total intraoperative time of surgery)
- Patient Satisfaction score(48 hours)
- VAS score for pain(48 hours)
- VAS score for nausea(48 hours)
研究者
Safie ramez tewfeik abd el moneim
Dr
Ain Shams University