此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Two-Point Versus Single-Point Serratus Anterior Plane Block for Post-Thoracoscopic Surgery Analgesia

2026年7月8日 更新者:Shiyou Wei

Comparison of Ultrasound-Guided Two-Point Combined vs Single-Point Serratus Anterior Plane Block for Postoperative Analgesia in Thoracoscopic Surgery: A Prospective Observational Cohort Study

Postoperative pain remains a common clinical challenge in patients undergoing video-assisted thoracoscopic surgery (VATS), impairing early recovery and increasing opioid consumption. The serratus anterior plane block (SAPB) is a widely used regional analgesic technique for thoracic surgery, but conventional single-point injection may have limited spread of local anesthetics, resulting in suboptimal analgesia in some patients. Preliminary anatomical evidence suggests that two-point combined SAPB may achieve wider dermatomal coverage and better analgesic efficacy.

This is a single-center, prospective observational cohort study conducted at Shanghai Pulmonary Hospital, China. A total of 88 adult patients scheduled for elective unilateral VATS will be consecutively enrolled and naturally assigned to either the two-point combined SAPB group (injection at the 3rd and 5th rib levels, total 30 ml local anesthetic) or the single-point SAPB group (injection at the 5th rib level, 30 ml local anesthetic) according to routine clinical practice.

The primary outcome is the verbal rating scale (VRS) pain score on coughing at 24 hours postoperatively. Secondary outcomes include resting and dynamic pain scores at multiple time points, cumulative opioid consumption at 24 and 48 hours, incidence of postoperative nausea and vomiting, block-related complications, length of hospital stay, and Quality of Recovery-15 (QoR-15) scores. This study aims to provide clinical evidence for optimizing perioperative analgesic strategies for thoracoscopic surgery.

研究概览

详细说明

Study Background Video-assisted thoracoscopic surgery (VATS) is the standard minimally invasive approach for thoracic diseases, yet over 60% of patients experience moderate-to-severe postoperative pain within 24 hours, which impairs respiratory function, increases opioid consumption and prolongs hospital stay. The serratus anterior plane block (SAPB) is a widely used fascial plane block for thoracic analgesia, but conventional single-point injection often yields inconsistent anesthetic spread due to individual anatomical variations, resulting in suboptimal analgesia in some patients. Preliminary anatomical and clinical evidence suggests that two-point combined SAPB may achieve wider dermatomal coverage and superior analgesic efficacy, but confirmatory evidence in VATS patients remains limited.

Study Design & Population This is a single-center, prospective observational cohort study conducted at Shanghai Pulmonary Hospital, China. A total of 88 eligible patients aged 18-85 years with ASA physical status I-III, scheduled for elective unilateral VATS and planned for perioperative SAPB, will be consecutively enrolled. Patients will be naturally allocated to the two-point group or single-point group according to the clinical regimen chosen by the attending anesthesiologist, with no researcher-initiated randomization. Exclusion criteria include local infection at the puncture site, allergy to amide local anesthetics, chronic opioid use, severe coagulopathy, and cognitive impairment precluding pain assessment.

Interventions & Outcomes All blocks are performed under ultrasound guidance by anesthesiologists with ≥50 prior SAPB experiences. The two-point group receives 15 ml of local anesthetic at both the 3rd and 5th rib levels (total 30 ml); the single-point group receives 30 ml at the 5th rib level. Standardized general anesthesia and postoperative analgesia protocols are applied uniformly to all patients. The primary outcome is the verbal rating scale (VRS) pain score on coughing at 24 hours postoperatively. Secondary outcomes include resting and dynamic pain scores at multiple time points, cumulative opioid consumption at 24 and 48 hours, incidence of postoperative nausea and vomiting, block-related complications, length of hospital stay, and QoR-15 recovery quality scores.

研究类型

观察性的

注册 (估计的)

88

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

This single-center, prospective observational cohort study is conducted at Shanghai Pulmonary Hospital, Tongji University School of Medicine, China. It enrolls adults aged 18-85 years with ASA physical status I-III, scheduled for elective unilateral video-assisted thoracoscopic surgery and planned for ultrasound-guided serratus anterior plane block as routine perioperative analgesia.Eligible participants will be consecutively enrolled after written informed consent. Patients are naturally assigned to two cohorts based on the block regimen selected by the attending anesthesiologist in standard clinical practice, with a target total sample size of 88 (~44 per cohort). No study-initiated randomization or treatment intervention is applied; all clinical management follows institutional routine protocols.

描述

Inclusion Criteria:

  • Aged 18 to 85 years at enrollment, regardless of sex
  • American Society of Anesthesiologists (ASA) physical status grade I to III
  • Scheduled for elective unilateral video-assisted thoracoscopic surgery
  • Planned to receive ultrasound-guided SAPB for routine perioperative analgesia
  • Able to understand study procedures and provide written informed consent

Exclusion Criteria:

  • Local infection or skin lesion at the block puncture site
  • Known hypersensitivity or allergy to amide local anesthetics
  • Preexisting sensory abnormality in the chest wall surgical area
  • Chronic opioid use for > 3 months, history of chronic pain syndrome, or history of opioid abuse
  • Severe coagulopathy (international normalized ratio > 1.5 or platelet count < 80 × 10⁹/L)
  • Cognitive impairment or inability to cooperate with postoperative pain assessment
  • Refusal to provide written informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Two-Point SAPB Group
Patients in this cohort receive ultrasound-guided two-point combined serratus anterior plane block for perioperative analgesia as part of routine clinical practice. A total of 30 mL local anesthetic is administered, with 15 mL injected deep to the serratus anterior muscle at the 3rd rib level and 15 mL at the 5th rib level.
Ultrasound-guided fascial plane block for perioperative thoracic analgesia. Local anesthetic is deposited deep to the serratus anterior muscle at two separate rib levels, with equal volume split between the 3rd and 5th intercostal spaces.
其他名称:
  • Two-Point SAPB; Double-Point Serratus Plane Block
Single-Point SAPB Group
Patients in this cohort receive ultrasound-guided single-point serratus anterior plane block for perioperative analgesia as part of routine clinical practice. A total of 30 mL local anesthetic is injected deep to the serratus anterior muscle at the 5th rib level in a single administration.
Ultrasound-guided fascial plane block for perioperative thoracic analgesia. A single bolus of local anesthetic is deposited deep to the serratus anterior muscle at the 5th intercostal level.
其他名称:
  • ingle-Point SAPB; Conventional Serratus Plane Block

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Verbal Rating Scale (VRS) Pain Score on Coughing at 24 Hours Postoperatively
大体时间:24 hours after surgery
Dynamic pain intensity assessed using a 0-10 verbal rating scale (0 = no pain, 10 = worst imaginable pain) when the patient performs coughing.
24 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
Resting Verbal Rating Scale (VRS) Pain Scores
大体时间:1 hour, 6 hours, 12 hours, 24 hours, 48 hours after surgery
Resting pain measured using a 0-10 verbal rating scale at multiple postoperative time points.
1 hour, 6 hours, 12 hours, 24 hours, 48 hours after surgery
Cumulative Postoperative Opioid Consumption
大体时间:24 hours and 48 hours after surgery
Total opioid consumption after surgery, converted to standard intravenous morphine equivalents.
24 hours and 48 hours after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
大体时间:Within 48 hours after surgery
Proportion of patients experiencing nausea and/or vomiting within 48 hours after surgery.
Within 48 hours after surgery
Incidence of Block-Related Adverse Events
大体时间:Within 48 hours after surgery
Proportion of patients with block-related complications, including pneumothorax, local hematoma, and local anesthetic toxicity.
Within 48 hours after surgery
Quality of Recovery-15 (QoR-15) Score
大体时间:24 hours and 48 hours after surgery
Patient-reported postoperative recovery quality assessed by the 15-item Quality of Recovery scale (total score range 0-150; higher score indicates better recovery quality).
24 hours and 48 hours after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Shiyou Wei、Tongji University Affiliated Shanghai Pulmonary Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2026年9月5日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅