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临床试验/NCT07830290
NCT07830290已完成不适用

Comparison of Erector Spinae Plane Block and Retrolaminar Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

Hacettepe University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Postoperative Pain Intensity Assessed Using the 11-Point Numeric Rating Scale

研究概览

简要总结

This study compared the postoperative analgesic efficacy of ultrasound-guided erector spinae plane (ESP) block and retrolaminar block in patients undergoing video-assisted thoracoscopic surgery (VATS). Adult patients were randomly assigned to receive either an ESP block or a retrolaminar block after induction of general anesthesia. Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) at predefined time points. Postoperative analgesic requirements and intraoperative opioid consumption were also evaluated.

详细描述

This prospective, randomized study was conducted in adult patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia. Participants were randomly assigned to receive either an ultrasound-guided erector spinae plane (ESP) block or an ultrasound-guided retrolaminar block after induction of general anesthesia.

The primary objective was to compare postoperative pain intensity between the two regional analgesic techniques. Pain intensity was assessed using the Numeric Rating Scale (NRS) at 1, 6, 12, and 24 hours after surgery. Additional outcomes included postoperative analgesic requirements, intraoperative remifentanil consumption, postoperative nausea and vomiting, and procedural characteristics of the blocks.

Postoperative pain assessment was performed by an investigator blinded to group allocation. The clinician responsible for determining the need for rescue analgesia was also unaware of the assigned block technique.

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

The investigator responsible for postoperative pain assessment using the Numeric Rating Scale (NRS) was blinded to group allocation. The clinician responsible for determining the need for rescue analgesia was also unaware of the assigned block technique. The anesthesiologist performing the block was not blinded due to the nature of the intervention

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 81 years
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Scheduled to undergo video-assisted thoracoscopic surgery (VATS)
  • Provided written informed consent to participate in the study

排除标准

  • ASA physical status III or higher
  • Decompensated organ failure
  • Pregnancy
  • Known allergy or hypersensitivity to local anesthetics
  • Withdrawal of consent or request to discontinue participation in the study

研究组 & 干预措施

Erector Spinae Plane Block Group

Experimental

Participants assigned to this group received an ultrasound-guided erector spinae plane (ESP) block after induction of general anesthesia. The block was performed as part of the perioperative analgesia protocol for video-assisted thoracoscopic surgery.

干预措施: Erector spinae plane block (ESP) (Procedure)

Retrolaminar Block Group

Experimental

Participants assigned to this group received an ultrasound-guided retrolaminar block after induction of general anesthesia. The block was performed as part of the perioperative analgesia protocol for video-assisted thoracoscopic surgery.

干预措施: Retrolaminar block group (Procedure)

结局指标

主要结局

Postoperative Pain Intensity Assessed Using the 11-Point Numeric Rating Scale

时间窗: 1, 6, 12, and 24 hours after surgery

Postoperative pain intensity was assessed using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Pain scores were recorded at 1, 6, 12, and 24 hours after surgery.

次要结局

  • Postoperative Analgesic Requirement(Within the first 24 hours after surgery)
  • Intraoperative Remifentanil Consumption(From induction of anesthesia until the end of surgery)
  • Postoperative Nausea and Vomiting (PONV)(Within the first 24 hours after surgery)
  • Number of Block Attempts(During block performance procedure)

研究者

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

YAKUP GÜDEK

Anesthesiology and Reanimation Resident

Hacettepe University

研究点 (1)

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