Comparison of Serratus Posterior Superior Intercostal Plane Block and Deep Serratus Anterior Plane Block After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
研究概览
简要总结
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) and Deep Serratus Anterior Plane Block in patients undergoing Video-Assisted Thoracoscopic Surgery. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, Quality of recovery assessed using the QoR-15 questionnaire.
详细描述
Study Objective
This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Serratus Posterior Superior Intercostal Plane (SPSIP) and Deep Serratus Anterior Plane Block on Visual Analog Scale (VAS) scores in patients undergoing Video-Assisted Thoracoscopic Surgery. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours and postoperative recovery quality.
Materials and Methods:
This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) <35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.The patients and the outcome assessors were blinded to group allocation. The anesthesiologist performing the block was not involved in postoperative data collection and was not blinded due to the nature of the intervention.
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 (Participant, 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
- •Patients aged 18-65 years
- •ASA physical status I-III
- •Scheduled for elective video-assisted thoracoscopic surgery
- •Body mass index (BMI) between 18 and 35 kg/m²
- •Ability to understand and use the patient-controlled analgesia (PCA) device
- •Ability to provide written informed consent
排除标准
- •Refusal to participate
- •Allergy to local anesthetics
- •Infection at the injection site
- •Coagulopathy or ongoing anticoagulant therapy
- •Chronic opioid use or opioid dependence
- •Severe hepatic or renal insufficiency
- •Pregnancy or breastfeeding
- •Cognitive impairment or inability to communicate pain scores
- •Body mass index (BMI) <18 or >35 kg/m²
研究组 & 干预措施
Serratus Posterior Superior Intercostal Plane Block
干预措施: Serratus Posterior Superior Intercostal Plane (SPSIP) block (Procedure)
Deep Serratus Anterior Plane Block
干预措施: Deep Serratus Anterior Plane Block (Deep SAP) (Procedure)
结局指标
主要结局
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
时间窗: 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative pain intensity (VAS score) Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Measurements will be recorded at predefined time points within the first 24 hours after surgery.
次要结局
- Requirement for rescue analgesia(Within the first 24 hours postoperatively)
- Block performance time(During the block procedure (intraoperative period))
- Total opioid consumption via patient-controlled analgesia (PCA)(Within the first 24 hours postoperatively)
- Block-related and systemic side effects(Within the first 24 hours postoperatively)
- Patient and Surgeon satisfaction assessed using a Likert scale(At 24 hours postoperatively)
- Quality of recovery assessed using the QoR-15 questionnaire(At 24 hours postoperatively)
- İncedence of postoperative nausea and vomiting(PONV)(At 24 hours postoperatively)
- Postoperative Shoulder Pain (VAS)(within the first 24 hours after surgery (0, 1, 4, 8, 12, and 24 hours))
研究者
Mustafa Kılın
Consultant Anesthesiologist
Antalya City Hospital