Comparison Between Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analog Score for pain
研究概览
简要总结
The goal of this clinical trial is to compare Ultrasound Guided Erector Spinae and Ultrasound Guided Serratus Anterior Plane Block post Modified Radical Mastectomy in adult females. the main questions it aims to answer are:
- Which of the two blocks has a better analgesic effect?
- Which of the two blocks is safer as regards inducing a pneumothorax and affecting the hemodynamics?
Participants:
- Will be divided into two groups after signing the informed consent.
- After being anesthetized and before surgical incision; the blocks will be given to the patient.
- Lung Ultrasound will be done for each patient to rule out pnemothorax once before the surgery and another after the end of surgery while the patient is being anesthetized.
- Patients that will experience pneuomothorax will be excluded from the study, and will be treated according to its size.
- Follow up of the patient for 24 hours postoperative to record the VAS score continuously, with giving increments of pethidine intravenously to relief pain.
详细描述
Breast surgeries belong to the most frequently performed procedures and are often associated with a high intensity of pain in the postoperative period.
Regional anesthesia techniques, have been the gold standard of postoperative pain management for breast surgeries. In recent years, the development of new techniques of regional anesthesia, which is due to the extensive implementation of ultrasound imaging, has enabled the use of a number of new blockades.The core mechanism of action in fascial blocks consists of blocking the nerve structures that supply a certain area of the trunk after deposition of local anesthetic within the fascial and fasciomuscular compartments. According to the current state of knowledge, the available options include Erector spinae plane block (ESPB) and Serratus anterior plane block (SAPB), however their recommendation in breast surgery requires more extensive scientific evidence.
Serratus anterior plane block acts on lateral branches of the intercostals nerves, blocking pain reception in the chest wall, while Erector spinae plane block involves the deposition of local anesthetic in the interfascial plane between erector spinae muscle and tips of the transverse processes of the vertebrae.
There is a scarcity of literature comparing ESPB and SAPB in patients undergoing breast surgeries.
Proponents of these techniques champion their ability to provide efficacious analgesia and anesthesia whereas critics cite a reportedly high failure rate and complications such as pneumothorax.
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, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status II, or III.
- •Age 21 - 65 years.
- •Female gender
排除标准
- •ASA IV, V, VI.
- •Infection at site of block.
- •Coagulopathy, or patients on antiplatelets, or anticoagulants.
- •Previous anesthetic allergy to bupivacaine.
- •Distant organ metastasis.
- •Male gender.
研究组 & 干预措施
Unilateral Erector Spinae group
-The patient will be turned to the lateral decubitus position and the surgical side superiorly. After proper sterilization; The linear probe will be put in a parasagittal plane over the transverse process of thoracic 4 or thoracic 5 vertebrae, approximately 2.5 cm lateral to the spinous processes. The transverse process has a square form contour as compared to the rib which is rounded form contour. Then the 3 muscle layers or sheets with facial plane are distinguished from superficial to deep as trapezius, rhomboid major, and erector spinae with flickering pleura in between the transverse processes. The block will be managed unilaterally by in-plane technique using 22-gauge, 50 mm, echogenic needle which will be inserted in a cranial-caudal orientation and the block needle will be proceeded through the trapezius, rhomboid major, and erector spinae to smoothly contact the transverse process. Needle location will be confirmed by hydro-dissection on injecting 2-3 ml normal saline.
干预措施: Unilateral Erector Spinae group (Procedure)
Unilateral Serratus Anterior group
-After skin sterilization, with the patient in the lateral decubitus position and the side of surgery superiorly, the ultrasound linear probe will be put longitudinally oblique just below the mid-clavicle. After distinguish the second rib, the probe will be mobilized caudally and laterally (obliquely), towards the mid-axillary line to distinguish the third, fourth and fifth ribs. The ideal and definite probe position has its cephalad end at the anterior axillary line and the caudal end at the posterior axillary line. The facial plane between the serratus anterior muscle and ribs four and five will be identified between the 4th and 5th rib in the mid-axillary region. Under sonar guided, 50 mm echogenic needle will be advanced in-plane to introduce this facial plane in cranio-caudal direction.
干预措施: Unilateral Serratus Anterior group (Procedure)
结局指标
主要结局
Visual Analog Score for pain
时间窗: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
* After extubation, the patient will be discharged from the operating room. VAS will be used to assess the postoperative pain (Myles et al., 2017). * Visual analogue scale score: Grade 0 (0-1 units on a scale): Good analgesia. Grade I (2-4 units on a scale): Moderate analgesia Grade II (5-7 units on a scale): Mild analgesia Grade III (8-10 units on a scale): No analgesia. * If VAS \>3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given. * VAS ranging from (0 units on a scale) no pain, to (10 units on a scale) severe intolerable pain;
次要结局
- Total dose of pethidine in mg.(at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively)
- Duration of analgesia postoperatively in hours.(at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively)
- Rate of vital data changes over the postoperative period(every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.)
- Incidence of pneumothorax(Intra-operatively)
研究者
Kholoud Usama
Assistant Lecturer
Ain Shams University