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临床试验/NCT07426692
NCT07426692已完成不适用

Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial

Marmara University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年3月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Postoperative pain intensity

研究概览

简要总结

This prospective randomized controlled trial was conducted to compare the effectiveness of two ultrasound-guided regional anesthesia techniques, erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB), with standard patient-controlled analgesia (PCA) for postoperative pain management after video-assisted thoracoscopic surgery (VATS).

Adult patients undergoing elective VATS were randomly assigned to receive ESPB, SPSIPB, or PCA alone. The primary objective was to evaluate postoperative pain intensity during the first 48 hours after surgery. Secondary outcomes included opioid consumption, rescue analgesia requirements, patient satisfaction, and postoperative complications.

详细描述

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive surgical technique; however, postoperative pain remains clinically significant and may delay recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have been increasingly incorporated into multimodal analgesia strategies in thoracic surgery.

This single-center, prospective, randomized controlled study included adult patients aged 18-75 years with ASA physical status I-III who were scheduled for elective VATS. After obtaining written informed consent and ethics committee approval, patients were randomly assigned in a parallel design to one of three groups: ESPB group, SPSIPB group, or control group receiving morphine patient-controlled analgesia (PCA) alone.

Both ESPB and SPSIPB were performed preoperatively under ultrasound guidance by an experienced anesthesiologist prior to induction of general anesthesia. Standardized general anesthesia and postoperative analgesia protocols were applied to all patients.

The primary outcome was postoperative pain intensity assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points up to 48 hours postoperatively. Secondary outcomes included cumulative morphine consumption, number of morphine demands, rescue analgesia requirements, patient satisfaction, and opioid-related adverse events.

The study aimed to determine whether SPSIPB provides analgesic efficacy comparable to ESPB and whether both regional techniques reduce opioid consumption compared with PCA alone.

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
Single (Outcomes Assessor)

盲法说明

Postoperative pain assessments were performed by clinicians who were blinded to group allocation in order to minimize assessment bias.

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

入选标准

  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective video-assisted thoracoscopic surgery (VATS)
  • Ability to understand and use patient-controlled analgesia device
  • Provided written informed consent

排除标准

  • - Coagulation disorders or current anticoagulant therapy
  • Infection at the block application site
  • Known allergy to local anesthetic agents
  • Anatomical abnormalities interfering with ultrasound-guided block
  • Severe cardiac, renal, or hepatic failure
  • Neurological or cognitive impairment preventing reliable pain assessment
  • Emergency surgery

研究组 & 干预措施

ESPB Group

Experimental

Patients received ultrasound-guided erector spinae plane block prior to induction of general anesthesia in addition to standard postoperative PCA.

干预措施: Erector Spinae Plane Block (ESPB) group (Procedure)

SPSIPB Group

Experimental

Patients received ultrasound-guided serratus posterior superior intercostal plane block prior to induction of general anesthesia in addition to standard postoperative PCA.

干预措施: Serratus posterior superior intercostal plane block (Procedure)

PCA Group

Active Comparator

Patients received standard postoperative morphine patient-controlled analgesia without regional block.

干预措施: Morfin (Drug)

结局指标

主要结局

Postoperative pain intensity

时间窗: 0 to 48 hours postoperatively

Postoperative pain assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.

次要结局

  • Cumulative morphine consumption(0 to 48 hours postoperatively)
  • Rescue analgesia requirements(12 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meliha Orhon

associate professor

Marmara University

研究点 (1)

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