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临床试验/NCT04537598
NCT04537598已完成不适用

Ultrasound Guided Continuous Erector Spinae Plane Block Versus Patient Controlled Analgesia in Patients Undergoing Nephrectomy for Renal Malignancies: A Randomized Controlled Study

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月3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
1
主要终点
measurement of visual analogue score

研究概览

简要总结

Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. It may also predispose patients to chronic post-surgical pain .Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection.Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain besides their side effects.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.

详细描述

Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. In addition to its early effects, poorly controlled acute postoperative pain may predispose patients to chronic post-surgical pain.

Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection, which is the main method for open nephrectomy at our institution, could make for better dissection of the renal pelvis and the pedicles, and provide the best circumstances for nephrectomy; however, it induces more persistent pain compared with other approaches.

Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain. In addition, opioids have many side effects like respiratory depression, nausea, vomiting and constipation hence it is important to decrease opioids use and the transition to other modalities such as regional blocks, nerve blocks, NSAIDs and multimodalities.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.

The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra. Hence, LA is distributed in the cranio-caudal fascial plane.Additionally, it diffuses anteriorly to the paravertebral and epidural spaces, and laterally to the intercostal space at several levels.

There are different case studies about the use of erector spinae block in nephrectomy but there is no randomized controlled study about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.

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
None

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

入选标准

  • Physical status ASA II.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.

排除标准

  • Patient refusal
  • Known sensitivity or contraindication to local anesthetics.
  • History of psychological disorders.
  • Localized infection at the site of block.
  • Coagulopathies with platelet count below 50,000 or an INR>1.5.

结局指标

主要结局

measurement of visual analogue score

时间窗: 1 week

it is a scoring system from 0 to 100 mm where 100 represents the worst pain and 0 indicates no pain

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ehab Hanafy Shaker

Assistant professor of Anesthesia, intensive care and pain releif

National Cancer Institute, Egypt

研究点 (1)

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