跳至主要内容
临床试验/NCT07348523
NCT07348523
招募中
不适用

Comparison of the Effectiveness of Classical and Modified Erector Spinae Plane Blocks in Postoperative Analgesia Management Following Lumbar Spinal Surgery: A Prospective Study

Samsun University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月2日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Samsun University
入组人数
60
试验地点
1
主要终点
Opioid consumption

概览

简要总结

The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery.

详细描述

Lumbar spinal stenosis may lead to variable signs and symptoms such as low back pain, radiating pain to the lower extremities, and reduced walking capacity. Lumbar disc surgery itself causes significant pain due to extensive dissection and muscle retraction during the procedure. A multimodal analgesic approach is preferred for postoperative pain management after lumbar spine surgery. The addition of regional anesthesia techniques reduces opioid-related side effects and is associated with earlier mobilization, shorter hospital stay, and improved patient satisfaction.

In patients undergoing lumbar disc surgery, the classical erector spinae plane block and the modified erector spinae plane block provide effective analgesia for postoperative pain control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-70 years,
  • Classified as ASA physical status I-III,
  • Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
  • Who agree to participate in the study by providing written informed consent

排除标准

  • History of bleeding diathesis or current anticoagulant therapy
  • Known allergy or hypersensitivity to local anesthetics or opioid medications
  • Infection at the planned block injection site
  • Previous lumbar spine surgery
  • History of gabapentinoid or corticosteroid use within the last 3 weeks
  • Inability to use a patient-controlled analgesia (PCA) device
  • Suspected pregnancy, confirmed pregnancy, or breastfeeding Refusal to undergo the procedure or to participate in the study

研究组 & 干预措施

Active Comparator: Group K-ESP

Active Comparator

The erector spinae plane block will be performed 30 minutes before lumbar spine surgery.

干预措施: The Classical Erector Spinae Plane Block (Other)

Active Comparator: Group M-ESP

Active Comparator

The modified erector spinae plane block will be performed 30 minutes before lumbar spine surgery.

干预措施: Modified Erector Spinae Plane Blocks (Other)

结局指标

主要结局

Opioid consumption

时间窗: 24 hours

In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.

次要结局

  • Perioperative pain intensity(24 hours)
  • Quality of recovery 15 scale(24 hours after surgery)
  • Postoperative nausea and vomiting(24 hours)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验