Preoperative Serratus Posterior Superior Intercostal Plane Block for Analgesia and Opioid Sparing in Patients Undergoing Minimally Invasive Cardiac Valve Surgery Via Mini-Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled 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
研究概览
简要总结
This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.
详细描述
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential.
Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors.
The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (bupivacaine or normal saline) will be prepared by an independent anesthesiologist according to the randomization sequence. The syringes will be identical in appearance, volume, and labeling. The anesthesiologist performing the block will not be aware of the syringe content.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-75 years
- •ASA physical status I-III
- •Scheduled for elective minimally invasive cardiac valve surgery via mini-thoracotomy
- •Able to understand and use the Numeric Rating Scale (NRS)
- •Provided written informed consent
排除标准
- •Age >75 years
- •Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
- •Coagulopathy or ongoing anticoagulant therapy that cannot be discontinued
- •Infection at the planned block site
- •Chronic opioid use or chronic pain conditions
- •Severe pulmonary disease affecting respiratory assessment
- •Neurological or psychiatric disorders interfering with pain assessment
- •Emergency surgery
- •Pregnancy or breastfeeding
- •Refusal to participate
研究者
Fatma Acil,MD
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital