EFFECTS OF SERRATUS POSTERIOR SUPERIOR INTERCOSTAL PLANE BLOCK ON PERIOPERATIVE INFLAMMATORY RESPONSE AND TLR-4 MEDİATED INNATE IMMUNE ACTIVATION IN BREAST CANCER SURGERY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, SHAM-CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in serum TLR4 concentration from baseline to 24 hours after surgery
研究概览
简要总结
This study will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery.
Participants will be randomly assigned to one of two groups. One group will receive an ultrasound-guided SPSIP block, while the other group will undergo a similar procedure without active medication (sham procedure). Both groups will receive standard general anesthesia and postoperative pain management.
Postoperative pain intensity, need for additional pain medication, nausea and vomiting, length of hospital stay, and persistent pain at 3 months after surgery will be assessed. Blood samples collected before surgery and at predetermined postoperative time points will be used to evaluate the body's inflammatory response to surgery and innate immune system activity. These assessments will include toll-like receptor 4 (TLR4), an immune-system marker, and selected inflammatory markers.
The main question of this study is whether the SPSIP block, compared with the sham procedure, reduces the surgery-related inflammatory response and improves postoperative pain outcomes.
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
Participants and outcome assessors will be blinded to group allocation. The anesthesiologist performing the SPSIP or sham procedure will not be blinded because of the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged 18 to 85 years.
- •Scheduled for elective breast cancer surgery under general anesthesia.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Able to provide written informed consent.
排除标准
- •Refusal to participate or inability to provide informed consent.
- •Allergy or contraindication to the study local anesthetic.
- •Coagulopathy or ongoing anticoagulant treatment contraindicating regional anesthesia.
- •Infection at the planned injection site.
- •Pre-existing chronic pain condition or regular opioid use.
- •Inability to communicate pain scores or comply with study assessments.
研究组 & 干预措施
SPSIP Block Group
Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with local anesthetic before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia.
干预措施: Serratus posterior superior intercostal plane block (Procedure)
Sham Block Group
Participants will undergo a simulated ultrasound-guided SPSIP procedure without local anesthetic injection before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia.
干预措施: Sham SPSIP Procedure (Procedure)
结局指标
主要结局
Change in serum TLR4 concentration from baseline to 24 hours after surgery
时间窗: Baseline (preoperative) to 24 hours after surgery
Serum Toll-like receptor 4 (TLR4) concentration will be measured by ELISA before the intervention (baseline, T0) and 24 hours after surgery (T4). The primary outcome is the change in TLR4 concentration between T0 and T4, compared between the SPSIP block and sham-control groups.
次要结局
未报告次要终点
研究者
Mucahide Emine Fidancı Kuas
Araştırma Görevlisi
Erol Olcok Corum Training and Research Hospital