The Effect of Bilateral Rhomboid Intercostal Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Bilateral Breast Implant Surgery: A Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total Tramadol Consumption Within the First 24 Hours Postoperatively
研究概览
简要总结
This prospective, randomized, single-center, study aims to evaluate the postoperative analgesic effectiveness of bilateral Rhomboid Intercostal Block (RIB) in patients undergoing elective bilateral breast prosthesis surgery. Effective postoperative pain management is essential to improve patient comfort and reduce opioid consumption.
Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to either receive ultrasound-guided bilateral RIB block in addition to standard general anesthesia or undergo surgery without any regional block (control group). All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia (PCA) with intravenous tramadol.
The primary outcome of the study is total tramadol consumption within the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at predefined time points, time to first analgesic requirement, need for rescue analgesia, incidence of nausea and vomiting, and block-related complications.
The results of this study will help determine whether bilateral RIB block provides superior postoperative pain control compared to standard analgesic management alone in bilateral breast prosthesis surgery.
详细描述
This prospective, randomized, single-center, single-blind clinical study is designed to evaluate the postoperative analgesic efficacy of bilateral Rhomboid Intercostal Block (RIB) in patients undergoing elective bilateral breast prosthesis surgery.
Patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective bilateral breast prosthesis surgery will be screened for eligibility. After obtaining written informed consent, participants will be randomly allocated into two groups using a computer-generated randomization sequence.
Group RIB: Patients will receive ultrasound-guided bilateral Rhomboid Intercostal Block in addition to standardized general anesthesia.
Control Group: Patients will undergo surgery under standardized general anesthesia without any regional block intervention.
The RIB procedure will be performed under aseptic conditions using ultrasound guidance. For each side, a total volume of 30 mL local anesthetic solution will be administered. The solution will consist of 5 mL of 2% lidocaine, 10 mL of 0.25% bupivacaine, and 15 mL of 0.9% sodium chloride, ensuring that maximum safe dosage limits are not exceeded.
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, Outcomes Assessor)
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
- •Female patients aged 18-65 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective bilateral breast prosthesis surgery
- •Ability to understand the study protocol and provide written informed consent
排除标准
- •Refusal to participate
- •Known allergy or hypersensitivity to local anesthetics (lidocaine or bupivacaine) or tramadol
- •Coagulation disorders or current anticoagulant therapy
- •Infection at the injection site
- •Chronic opioid use or chronic pain syndromes
- •Severe hepatic, renal, or cardiac disease
- •Neurological or psychiatric conditions interfering with pain assessment
- •Body mass index (BMI) > 35 kg/m²
- •Pregnancy or breastfeeding
研究组 & 干预措施
Rhomboid Intercostal Plane Block
Ultrasound-guided bilateral rhomboid intercostal plane block (RIPB) will be performed preoperatively under aseptic conditions while patients are awake. A total of 30 mL local anesthetic solution will be administered per side between the rhomboid major muscle and the intercostal muscles at the medial border of the scapula around the 5th intercostal level.
The local anesthetic mixture will consist of 5 mL of 2% lidocaine, 10 mL of 0.25% bupivacaine, and 15 mL of 0.9% normal saline, ensuring that maximum safe dosage limits are not exceeded.
干预措施: Rhomboid intercostal plane block (Procedure)
Control Group (No Block)
Patients in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.
结局指标
主要结局
Total Tramadol Consumption Within the First 24 Hours Postoperatively
时间窗: 0 to 24 hours postoperatively
Total amount of tramadol (mg) administered via patient-controlled analgesia (PCA) during the first 24 postoperative hours.
次要结局
未报告次要终点
研究者
Konul Karaja
Professor, Department of Anesthesiology and Reanimation
Aydin Adnan Menderes University