The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.
详细描述
The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients will be under general anesthesia and will not know if they received a block procedure or not.
The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I-II patients
- •Ages between 18-65
- •Patients who will receive breast cancer surgery under general anesthesia
排除标准
- •Known respiratory diseases
- •Rhinitis and atopic dermatitis story
- •New York Heart Association Class equal to higher than class 2
- •Respiratory diseases story in the last two weeks
- •Alchol or substance or chronic opioid consumption story
- •Any pain killers intake in the last 24 hours prior to surgery
- •Active smokers or ex-smokers
- •Body mass index over 35 kg/m2
- •İnfection at the injection sites
- •Known allergy to local anesthetics
- •Known psychiatric diseases
- •Operations longer than 3 hours
结局指标
主要结局
Forced Expiratory Volume in 1 second (FEV1)
时间窗: postoperative 2nd hour
FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
次要结局
- Postoperative pain(Postoperative second hour)
- Postoperative opioid consumption(Postoperative 24th hour)
- FEV1/FVC(postoperative 2nd hour)
- forced expiratory flow at 25-75% of forced vital capacity (FEF25-75)(postoperative 2nd hour)
- Peak expiratory flow (PEF)(postoperative 2nd hour)
- Forced Vital Capacity (FVC)(postoperative 2nd hour)
研究者
Başak Altıparmak
Associated Prof Dr
Muğla Sıtkı Koçman University