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临床试验/NCT05448495
NCT05448495Unknown4 期

Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy. A Prospective Randomized Clinical Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月13日最近更新:
适应症

试验速览

阶段
4 期
入组人数
60
试验地点
2
主要终点
The time to first call rescue analgesia

研究概览

简要总结

To compare the analgesic efficacy of posterior TAP block versus ESPB after PCNL surgery. The hypothesis is that posterior TAP block, as a part of multimodal analgesia, will reduce pain and opioid consumption like ESPB

详细描述

Percutaneous nephrolithotomy (PCNL) is currently the gold standard for treatment of patients with large and complex renal calculi because it is less invasive than open surgery. The sources of acute pain after PCNL are visceral pain originating from kidneys and ureters, and somatic pain from the site incision. PCNL is usually done in 10th to 11th intercostal space or in the subcostal area. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as thoracic paravertebral block, transversus abdominis plane (TAP) block, erector spinae plane block (ESPB).

ESPB is an interfascial block which can provide wide sensory blockade from T2-4 to L1-2 that was first described in 2016. ESPB can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle with nearly one dermatome for each 3.4 ml of the injected volume. This allows ESPB to provide both visceral and somatic analgesia. TAP block is a regional injection of a local anesthetic agent between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1). Various technical modifications in TAP block have been described including lateral, posterior, subcostal, and continuous catheter techniques. The posterior approach should be the preferred technique in clinical practice as it provides longer somatic and visceral analgesia that are not offered with the lateral approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (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 scheduled for PCNL under general anesthesia
  • ASA status I-II

排除标准

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)
  • Patient who has difficulty understanding the study protocol or patient refusal.
  • Chronic respiratory disease patients.
  • Diabetic patients.
  • Body mass index (BMI) > 30 Kg/m2
  • Routine corticosteroids, pain medication, or anticonvulsant.
  • Psychiatric diseases.

结局指标

主要结局

The time to first call rescue analgesia

时间窗: From end of surgery till 24 hours

次要结局

未报告次要终点

研究者

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

FATMA NABIL AHMED MOHAMED

Clinical Professor

Assiut University

研究点 (2)

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