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临床试验/NCT06477198
NCT06477198已完成不适用

Posterior Quadratus Lumborum Block vs Erector Spinae Plane Plane Block for Pain Management After Lumbar Spinal Surgery

Medipol University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Postoperative pain scores (NRS-Numerical Rating Scala)

研究概览

简要总结

Ultrasound-guided quadratus lumborum block (QLB) is a fascial plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle to anesthetize the thoracolumbar nerves.

The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. at 2016. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. It has been reported that ESPB provides lumbar analgesia at T10-12, L3.

This study aims to compare US-guided ESPB and posterior QLB for postoperative analgesia management after lumbar disc herniation-laminectomy surgery.

详细描述

Spine surgery in thoracolumbar region is one of the most common surgeries performed for the treatment of leg and back pain. Pain management is especially important for these patients since chronic pain often occurs after surgery. Severe pain may occur at postoperative period in patients following lumbar disc herniation (LDH) operation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Opioids are one of the most preferred drugs among the analgesic agents. Parenteral opioids are generally performed for patients after surgery. However opioids have undesirable adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events).

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment. US-guided interfascial plane blocks have been used increasily due to the advantages of ultrasound in anesthesia practice. Ultrasound-guided quadratus lumborum block (QLB) is a fascial plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle to anesthetize the thoracolumbar nerves.

The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. at 2016 The ESPB contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. Visualization of sonoanatomy with US is easy, and the spread of local anesthetic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves. ESPB provides thoracic analgesia at the T5 level, abdominal analgesia at the T7-9 level, and lumbar analgesia at T10-12, L3 level. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery.

This study aims to compare US-guided posterior QLB block and ESPB for postoperative analgesia management after lumbar disc herniation-laminectomy surgery. The primary aim is to compare postoperative pain scores (NRS) the secondary aim is to evaluate postoperative opioid consumption, motor block, and adverse effects related to opioids (allergic reaction, nausea, vomiting).

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 (Participant, Outcomes Assessor)

盲法说明

Outcomes Assessor and participant were blinded to the study

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

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for lumbar disc herniation-laminectomy surgery under general anesthesia

排除标准

  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedure
  • Change in surgical technique in the intraoperative period

结局指标

主要结局

Postoperative pain scores (NRS-Numerical Rating Scala)

时间窗: Postoperative 2 hours period

Difference in the NRS scores at postoperative 2 hours between the groups

次要结局

  • The use of rescue analgesia (number of participants) (frequency of rescue analgesia)(Postoperative 24 hours period)
  • The use of rescue analgesia (rate of tramadol using) (total consumption)(Postoperative 24 hours period)
  • Postoperative pain scores (NRS-Numerical Rating Scala)(Changes from baseline pain scores at postoperative 1, 4, 8, 16 and 24 hours)
  • The incidence of adverse events(Postoperative 24 hours period)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahadir Ciftci

Principal Investigator

Medipol University

研究点 (2)

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