Comparison of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Quality of Recovery After Video-Assisted Thoracoscopic Surgery: A Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Quality of Recovery-15 (QoR-15) Score
研究概览
简要总结
Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain despite its minimally invasive nature. Ultrasound-guided erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB) are promising regional analgesic techniques for thoracic surgery; however, evidence directly comparing their effects on postoperative quality of recovery remains limited. This prospective, randomized, double-blind controlled trial aims to compare the effects of ESPB and SPSIPB on postoperative quality of recovery, measured by the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes include postoperative pain scores, tramadol consumption, time to first rescue analgesia, rescue analgesic requirement, postoperative nausea and vomiting, patient satisfaction, length of hospital stay, block-related complications, and perioperative hemodynamic parameters.
详细描述
Video-assisted thoracoscopic surgery (VATS) has become the preferred surgical approach for many thoracic procedures because of its minimally invasive nature. Nevertheless, patients frequently experience moderate to severe postoperative pain, which may impair respiratory function, delay mobilization, prolong hospitalization, and negatively affect overall recovery. Effective multimodal analgesia is therefore essential for optimizing postoperative outcomes.
Ultrasound-guided erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB) are interfascial plane blocks that have demonstrated promising analgesic efficacy in thoracic surgery. Although both techniques are increasingly used in clinical practice, evidence directly comparing their effects on postoperative quality of recovery following VATS is limited.
This prospective, randomized, double-blind, parallel-group clinical trial will enroll 128 adult patients (18-70 years, ASA physical status I-III) undergoing elective VATS. Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided ESPB or ultrasound-guided SPSIPB before surgery.
The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes include postoperative pain scores at rest and during coughing, cumulative 24-hour tramadol consumption, time to first rescue analgesia, rescue analgesic requirement, postoperative nausea and vomiting, sedation level, patient satisfaction, length of hospital stay, block-related complications, perioperative hemodynamic variables, and additional analgesic requirements.
The results of this study are expected to provide high-quality evidence regarding the comparative effectiveness of ESPB and SPSIPB in improving postoperative recovery and analgesic outcomes after VATS and may contribute to optimizing regional analgesia strategies for thoracic 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 (Participant, Outcomes Assessor)
盲法说明
Participants and postoperative outcome assessors will be blinded to treatment allocation. Ultrasound-guided blocks will be performed by an experienced anesthesiologist who will not participate in postoperative assessments.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-85 years.
- •ASA physical status I-III.
- •Scheduled for elective VATS under general anesthesia.
- •Able to understand and complete the QoR-15 questionnaire.
- •Written informed consent provided.
排除标准
- •Refusal to participate or inability to provide written informed consent.
- •Known allergy or contraindication to bupivacaine, paracetamol, dexketoprofen, or tramadol.
- •Infection at the planned block injection site.
- •Coagulopathy or ongoing anticoagulant therapy precluding regional anesthesia.
- •Severe hepatic or renal insufficiency.
- •Chronic opioid use or chronic pain requiring regular analgesic treatment.
- •Previous thoracic surgery on the operative side.
- •Pregnancy or breastfeeding.
- •Cognitive impairment, psychiatric illness, or language barrier preventing completion of the QoR-15 questionnaire.
- •Body mass index (BMI) >35 kg/m².
- •Conversion from VATS to thoracotomy.
- •Failed or incomplete regional block.
结局指标
主要结局
Quality of Recovery-15 (QoR-15) Score
时间窗: 24 hours after surgery
Postoperative quality of recovery will be assessed using the validated Turkish version of the Quality of Recovery-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery. The preoperative QoR-15 score will be recorded as a baseline measurement and considered in the analysis of the postoperative 24-hour score.
次要结局
- Postoperative Pain at Rest(30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.)
- Postoperative Pain Intensity During Coughing(30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.)
- Time to First Rescue Analgesia(During the first 24 hours after surgery)
- Cumulative Postoperative Tramadol Consumption(During the first 24 hours after surgery)
- Requirement for Rescue Analgesia(During the first 24 hours after surgery)
- Postoperative Nausea and Vomiting Impact Score(During the first 24 hours after surgery)
- Patient Satisfaction With Postoperative Analgesia(24 hours after surgery)
- Postoperative Length of Hospital Stay(From surgery until hospital discharge (up to 30 days))
- Incidence of Block-Related Complications(From block performance until hospital discharge (up to 30 days))
研究者
Fatma Acil,MD
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital