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临床试验/NCT07275047
NCT07275047招募中不适用

Comparison of Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Paravertebral Block for Postoperative Analgesia After Thoracotomy

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Postoperative 24-Hour PCA Opioid Consumption

研究概览

简要总结

Thoracotomy causes severe postoperative pain that may impair respiratory function and increase complications. This study compares the postoperative analgesic effectiveness of the serratus posterior superior intercostal plane (SPSIP) block and the paravertebral block in patients undergoing thoracotomy. The aim is to determine whether the newly described serratus posterior superior intercostal plane block can serve as a safe and effective alternative to established techniques.

详细描述

Thoracotomy often causes strong postoperative pain because the ribs, muscles, nerves, and pleura are affected during surgery. This pain can make it difficult for patients to breathe well and may increase the chance of lung problems. Paravertebral block is a well-known method for reducing pain after thoracic surgery, but it can sometimes lead to side effects such as low blood pressure or complications related to deeper needle placement.

The serratus posterior superior intercostal plane block is a newer ultrasound-guided technique. In this method, local anesthetic is injected between the serratus posterior superior muscle and the intercostal muscles. Early studies suggest that it may provide wide pain relief, but its effectiveness specifically in thoracotomy patients has not yet been studied.

This randomized study aims to compare the pain-relieving effects of the serratus posterior superior intercostal plane block with those of the paravertebral block after thoracotomy. The goal is to find out whether this new block can be a safe and effective option for postoperative pain management.

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 (Investigator, 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

  • •Scheduled to undergo thoracotomy
  • •ASA physical status I-III according to the American Society of Anesthesiologists classification
  • •Able to understand the study procedures and provide written informed consent

排除标准

  • •Declines or is unable to provide informed consent
  • •Allergy or hypersensitivity to local anesthetics or opioids
  • •Known or suspected coagulopathy
  • •Infection at the injection site
  • •History of thoracic surgery
  • •Severe cardiovascular disease
  • •Hepatic or renal failure
  • •Pregnant, suspected pregnancy, or breastfeeding
  • •Significant neurological or psychiatric disorder that may interfere with study participatio

研究组 & 干预措施

Group SPSIP

Active Comparator

Participants in this arm will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane Block. The block will be performed preoperatively with the patient in the appropriate position. A local anesthetic solution will be injected between the serratus posterior superior muscle and the intercostal muscles under real-time ultrasound guidance. The technique aims to achieve postoperative analgesia by providing sensory blockade across targeted thoracic dermatomes. No additional regional block will be performed in this group.

干预措施: Serratus Posterior Superior Intercostal Plane Block (Procedure)

Group Paravertebral

Active Comparator

Participants in this arm will receive an ultrasound-guided thoracic paravertebral block. The block will be performed preoperatively with the patient in the appropriate position. Under real-time ultrasound guidance, a local anesthetic solution will be injected into the thoracic paravertebral space at the planned level to achieve unilateral somatic and sympathetic nerve blockade. This intervention is intended to provide postoperative analgesia following thoracotomy. No additional regional block will be administered in this group.

干预措施: Thoracic Paravertebral Block (Procedure)

结局指标

主要结局

Postoperative 24-Hour PCA Opioid Consumption

时间窗: Postoperative 24 hours

Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).

次要结局

  • QoR-15 Recovery Score(The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.])
  • NRS Pain Scores at Rest and Movement(2, 4, 8, 16, 24, and 48 hours postoperatively)
  • QoR-15 Recovery Score(The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.])
  • Chronic Pain Assessment(3 months postoperatively)
  • Rescue Analgesic Requirement(Postoperative 0-48 hours)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mursel Ekinci

Assoc Prof

Bursa City Hospital

研究点 (1)

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