Postoperative Analgesic Efficacy of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative 48-Hour PCA Opioid Consumption
研究概览
简要总结
This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery.
详细描述
Most patients undergoing arthroscopic shoulder surgery report pain in the postoperative period. Pain management remains a significant concern in patient management, as it affects surgical costs, postoperative mobility, length of hospital stay, patient satisfaction, and surgical outcomes. Multimodal analgesia is recommended for the management of postoperative pain. Regional analgesia is an important component of multimodal analgesia.
The serratus posterior superior intercostal plane (SPSIP) block is a novel regional analgesia technique described in 2023. SPSIP has been reported to provide near-complete sensory blockade in the posterior neck, shoulder, and hemithorax regions.
The main objective of this study is to investigate the effectiveness of SPSIP block in patients undergoing arthroscopic shoulder surgery.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classified as American Society of Anesthesiologists (ASA) physical status I-II-III
- •Scheduled for elective shoulder arthroscopy surgery
- •Surgery performed under general anesthesia
- •Provision of written informed consent
排除标准
- •Use of anticoagulant or antiplatelet medications
- •Presence of bleeding diathesis or coagulation disorders
- •Known allergy or hypersensitivity to local anesthetics or opioid medications
- •Infection or history of previous surgery at the planned block site
- •Alcohol or drug dependence
- •Cognitive impairment preventing reliable pain assessment using the NRS
- •Pregnancy or lactation
- •Diabetes mellitus
- •Renal or hepatic impairment
研究组 & 干预措施
Group SPSIP
Group SPSIP Participants in this arm will receive an ultrasound-guided serratus posterior plane block .
干预措施: Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP) (Procedure)
Group Control
No block procedures will be performed on patients in this arm
结局指标
主要结局
Postoperative 48-Hour PCA Opioid Consumption
时间窗: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams(mg)
次要结局
- QoR-15 Recovery Score(Postoperative 24th and 48th hours)
- Dynamic and static NRS scores(0, 2, 4, 8, 16, 24, and 48 hours postoperatively)
- Total rescue analgesic dose(Postoperative 24th and 48th hours)
- Time of first request for rescue analgesia,(Postoperative 48-Hours)
- Length of Hospital Stay(the day of surgery, the day of discharge from the hospital)
- Block and Opioid-Related Adverse Effects and Complications(Postoperative 48-Hours)
- Perioperative Remifentanil infusion dose(Start time: Start of anesthesia administration End time: Termination of anesthesia administration)
研究者
Merih Yıldız Eglen
Principal Investigator, MD
Bursa City Hospital