Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Postoperative Pain Scores (NRS)
研究概览
简要总结
This prospective, randomized, assessor-blinded trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia.
The primary outcome is postoperative pain scores within the first 24 hours. The secondary outcome is opioid consumption.
详细描述
This prospective, randomized, assessor-blinded, single-center clinical trial is designed to compare the effects of serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery. Eligible adult female patients will be randomly assigned in a 1:1 ratio to receive either SPSIPB or ESPB under ultrasound guidance prior to induction of general anesthesia.
All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time points within the first 24 hours, both at rest and during movement. The primary outcome is postoperative pain scores within 24 hours. The secondary outcome is total opioid consumption during the same period.
This study aims to determine whether SPSIPB provides comparable or superior analgesia compared to ESPB in unilateral breast surgery.
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, Outcomes Assessor)
盲法说明
The patient and the outcome assessor will be blinded to group allocation. The anesthesiologist performing the block will not be blinded.
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
- •ASA physical status I-III
- •Body mass index (BMI) between 18 and 35 kg/m²
- •Scheduled for elective unilateral breast surgery (mastectomy with or without sentinel lymph node biopsy)
- •Ability to understand and provide written informed consent
排除标准
- •Infection at the site of block application
- •Known allergy to local anesthetics
- •Coagulopathy or anticoagulant therapy
- •Chronic opioid use
- •Pregnancy
- •Inability to communicate or cooperate
- •Refusal to participate
- •Failed block
- •Requirement of additional intraoperative analgesia outside the study protocol
- •Development of serious intraoperative complications
研究组 & 干预措施
SPSIP Block
Participants will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia.
干预措施: Serratus Posterior Superior Intercostal Plane Block (Procedure)
ESPB Block
Participants will receive an ultrasound-guided erector spinae plane block (ESPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia.
干预措施: Serratus Posterior Superior Intercostal Plane Block (Procedure)
结局指标
主要结局
Postoperative Pain Scores (NRS)
时间窗: T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates worst imaginable pain). Pain scores will be evaluated both at rest and during movement (coughing)
次要结局
- Total Opioid Consumption(T0-T1: 0-1 hour, T1-T2: 1-4 hours, T2-T3: 4-8 hours, T3-T4: 8-12 hours, and T4-T5: 12-24 hours postoperatively)
研究者
Engin Çetin
principal investigator
Kocaeli City Hospital