Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block for the Prevention of Chronic Postoperative Pain After 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
- 90
- 试验地点
- 1
- 主要终点
- Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form
研究概览
简要总结
This prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. The primary outcome is chronic postoperative pain at 3 months, assessed using the Brief Pain Inventory-Short Form.
详细描述
This single-center, prospective, randomized, controlled, assessor-blinded study will include adult female patients scheduled for elective unilateral breast surgery. Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block or erector spinae plane block before general anesthesia.
The study aims to compare the effects of these two regional anesthesia techniques on chronic postoperative pain at 3 months. Chronic pain will be assessed using the Brief Pain Inventory-Short Form.
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
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: Ultrasound-guided Erector Spinae Plane Block (Procedure)
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)
结局指标
主要结局
Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form
时间窗: Time Frame: T0: 3 months postoperatively
Chronic postoperative pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF assesses pain severity (worst, least, average, and current pain) and pain interference with daily activities. Pain severity items are scored on a 0-10 numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Pain interference items are scored on a 0-10 numeric rating scale (0 = does not interfere; 10 = completely interferes). Higher scores indicate worse pain severity and greater pain-related interference.
次要结局
- Neuropathic Pain Assessed by the DN4 Questionnaire(T0: 3 months postoperatively)
研究者
Engin Çetin
principal investigator
Kocaeli City Hospital