Erector Spinae Block Versus PECS Block Type II for Breast Surgeries: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total morphine consumption for 24 hours post operatively
研究概览
简要总结
The purpose of this randomized, controlled prospective study is to compare the analgesic effect of US-guided ESP block versus PECs block in patients undergoing breast surgery for breast cancer in the National Cancer Institute, Cairo University. We aim to evaluate the postoperative pain intensity and opioid consumption within 24 hours
详细描述
This prospective, randomized controlled trial will include 30 adult female patients below 65 years of age scheduled for surgery for breast cancer. Inclusion criteria will include also American Society of Anesthesiologists (ASA) physical status I-II and unilateral surgery. Exclusion criteria will include obesity defined as body mass index > 35 kg/m2), known allergy to the study drugs, coagulopathy, skin infection at the site of needle puncture, and recent use of opioid drugs.
Patients will be assessed the day before surgery in a preoperative visit for evaluation of their medical status and laboratory investigations. They will be informed about the technique of the blocks and written informed consents will be obtained. All patients will be informed how to report pain on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). In the pre-anesthetic room, midazolam 0.02 mg/kg IV will be given to the patients for sedation after fixation of a 20 G cannula as an IV line. Randomization will be done using consecutively numbered opaque sealed envelopes. Patients will be randomized into two groups according to the type of analgesia. The first group will receive single-shot ESP block (ESP group) and the other group will receive PECs II block (PECs group).
ESP technique:
ESP block will be performed in following standardized monitoring, including noninvasive blood pressure, electrocardiogram, and pulse oximetry. It will be done unilaterally with the patient in the prone position about 20 min before induction of general anesthesia. Skin is prepared by 10% povidone iodine. The US probe will be covered with a sterile cover. All blocks will be by the same anesthesiologists who are experienced in US-guided nerve blocks. An ultrasound machine with a large bandwidth, multifrequency convex probe (1-8 MHz) will be used for block performance. A 22G, 50-mm, insulated facet type needle will be used during all blocks. The blocks will be performed at the T4 level of the spine using an in-plane approach. A convex probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Once the erector spinae muscle and the transverse processes is identified, the needle will be inserted deep into the muscle. The needle will be directed from a cranial to a caudal direction. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of local anesthetic, 20 ml of 0.25% bupivacaine will be administered for block performance. Distribution of local anesthetic will be observed in both cranial and caudal directions.
PECs II block Technique:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years old)
- •Female sex
- •Scheduled for breast surgeries at NCI, CU
排除标准
- •Patient's refusal of the study procedures
- •Allergy to drugs used in the study
- •Patients with chronic pain and chronic use of opioids
- •Patients with coagulopathies (INR > 1.6 or platelets count < 50,000 cc3)
- •Hemodynamically unstable patients (e.g. BP < 90/60)
- •Patients with local or systemic infections concerning intervention sites and septic patients
结局指标
主要结局
Total morphine consumption for 24 hours post operatively
时间窗: 24 hours
The primary outcome measure of the study will be total morphine consumption during the first 24 postoperative hours.
次要结局
- duration of analgesia(24 hours)
- post operative pain scores using numerical rating scale(24 hours)
- post operative nausea and vomiting using nausea score(24 hours)
研究者
Ahmed Bakir
Assistant Professor of Anesthesia, Intensive care and Pain relief
National Cancer Institute, Egypt
