Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Reduction Surgery: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total Tramadol Consumption Within the First 24 Hours After Surgery
研究概览
简要总结
This prospective, randomized clinical study aims to compare the analgesic efficacy of serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) for postoperative analgesia in patients undergoing elective bilateral breast reduction surgery under general anesthesia. All patients will receive standardized general anesthesia. Before induction of anesthesia, while patients are awake, Group SPB will receive an ultrasound-guided serratus anterior plane block and Group RIPB will receive an ultrasound-guided rhomboid intercostal plane block. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (PCA) with opioids. Primary outcomes include postoperative pain scores and opioid consumption at 1, 6, 12, and 24 hours. Secondary outcomes include time to first analgesic demand, patient satisfaction, and block-related complications.
详细描述
Postoperative pain management in breast reduction surgery is challenging due to wide tissue dissection and thoracic wall involvement. Serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) are regional anesthesia techniques that provide analgesia by blocking the lateral cutaneous branches of the intercostal nerves.
This randomized controlled trial will compare the analgesic efficacy of SPB and RIPB in female patients aged 18-65 undergoing elective bilateral breast reduction surgery under general anesthesia.
Before induction of general anesthesia, while patients are awake, ultrasound-guided SPB or RIPB will be performed according to group allocation. After block performance, general anesthesia will be induced using a standardized protocol. Postoperative pain management will be provided with intravenous patient-controlled analgesia (PCA) with opioids.
Primary outcomes include postoperative pain scores (NRS) and opioid consumption. Secondary outcomes include duration of analgesia, time to first analgesic request, patient satisfaction, and block-related complications. The hypothesis is that both blocks will reduce postoperative pain and opioid consumption, but the duration and quality of analgesia may differ between SPB and RIPB.
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
- None (Participant, Outcomes Assessor)
盲法说明
The patients and the outcome assessor who recorded postoperative pain scores were blinded to the type of block performed
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 reduction surgery under general anesthesia
- •Willing and able to provide written informed consent
排除标准
- •Allergy or contraindication to local anesthetics (bupivacaine)
- •Coagulopathy or anticoagulant medication use
- •Infection at or near the injection site
- •History of chronic opioid use or psychiatric/neurological disorders affecting pain perception
- •Body mass index (BMI) > 35 kg/m²
- •Refusal to participate in the study
研究组 & 干预措施
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
干预措施: No Regional Block (Control) (Other)
Serratus Plane Block
"Patients in this group will receive an ultrasound-guided serratus anterior plane block (SAPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered to the right side and 15 mL to the left side. Each side will receive a single injection point along the midaxillary line to provide adequate spread within the serratus plane.
干预措施: Serratus Anterior Plane Block (SAPB) (Procedure)
Rhomboid Intercostal Plane Block
"Patients in this group will receive an ultrasound-guided rhomboid intercostal plane block (RIPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered on the right and 15 mL on the left. Each side will receive a single injection point beneath the medial border of the scapula at the level of the intercostal plane to ensure adequate spread between the rhomboid major muscle and intercostal muscles."
干预措施: Rhomboid Intercostal Plane Block (RIPB) (Procedure)
结局指标
主要结局
Total Tramadol Consumption Within the First 24 Hours After Surgery
时间窗: 24 hours after surgery
Total opioid consumption will be recorded using intravenous patient-controlled analgesia (PCA) during the first 24 hours after surgery. The cumulative tramadol dose (mg) administered via PCA will be calculated based on the number of patient-controlled bolus doses.
Postoperative Pain Score at Rest and During Movement at 1, 6, 12, and 24 Hours
时间窗: 24 hours after surgery
Pain intensity will be assessed using the Numeric Rating Scale (NRS), a 0-10 point scale where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at rest and during movement at 1, 6, 12, and 24 hours after surgery. All patients will receive intravenous patient-controlled analgesia (PCA) for postoperative pain management.
次要结局
- Postoperative Pain Scores (NRS) at Rest and During Movement at 1, 6, 12, and 24 Hours(1, 6, 12, and 24 hours after surgery)
研究者
Konul Karaja
Anesthesiology Research Fellow / MD
Aydin Adnan Menderes University