此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Efficacy of Ultrasound-Guided Erector Spinae Block for Postoperative Pain Management in Nephrectomy

2026年4月24日 更新者：Kazi Mahzabin Arin、Bangladesh Medical University

Efficacy of Ultrasound-Guided Erector Spinae Plane Block in Postoperative Pain Management in Nephrectomy: A Randomized Controlled Trial

This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). The study will compare this new technique to traditional pain management methods, such as opioid medications, to assess whether the ESP block reduces pain and the need for opioids after surgery.

Patients will be randomly assigned to one of two groups:

Group C will receive conventional pain relief methods, including opioids. Group E will receive the ultrasound-guided ESP block in addition to general anesthesia.

The main goals are to determine:

How much pain relief each method provides, measured using a visual analog scale (VAS).

The total amount of opioids required during the first 24 hours post-surgery.

Additional measurements will include monitoring vital signs like heart rate, blood pressure, and oxygen levels.

This study will help find safer and more effective ways to manage pain after nephrectomy, reducing the reliance on opioids and improving patient recovery

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This randomized controlled trial aims to assess the efficacy of ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain in patients undergoing open nephrectomy. Nephrectomy, a common procedure for kidney removal, often results in severe postoperative pain, which can contribute to complications such as postoperative pulmonary complications (PPC) and delayed recovery. Traditional analgesic techniques, including systemic opioids and epidural analgesia, have various side effects such as nausea, vomiting, constipation, and respiratory depression. Additionally, opioids may lead to tolerance, especially in cancer patients. Erector spinae plane block (ESP) is a newer regional technique that has gained attention due to its potential to provide effective analgesia with minimal side effects.

This study will evaluate whether the ESP block can provide better pain control and reduce opioid consumption compared to conventional pain management techniques. The ESP block targets the erector spinae muscle and provides analgesia via fascial plane blocks, which is believed to be effective in controlling visceral and somatic pain, typically associated with nephrectomy.

The trial will involve 66 adult patients scheduled for open nephrectomy under general anesthesia. Patients will be randomly assigned to one of two groups:

Control Group (Group C): Patients will receive conventional analgesia, including opioids and standard local anesthetic techniques.

Intervention Group (Group E): Patients will receive general anesthesia combined with the ultrasound-guided ESP block, administered immediately before anesthesia induction.

The primary outcome of the trial is to measure the first postoperative opioid requirement, utilizing the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes include the total opioid consumption in the first 24 hours, the intensity of postoperative pain at various time points, and the hemodynamic responses (heart rate, blood pressure). Additionally, peak expiratory flow rate (PEFR) will be monitored to assess respiratory function as part of the recovery process.

By evaluating these outcomes, the study aims to provide insights into whether ESP block can serve as a safer, effective alternative to traditional analgesia, improving postoperative pain management and reducing the risks associated with opioid use. The results may guide clinical practice in nephrectomy pain management, offering a potential improvement in patient recovery times and satisfaction.

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult patients aged 18 to 64 years
  • Scheduled for open nephrectomy (radical or partial) under general anesthesia
  • ASA physical status I-II (American Society of Anesthesiologists classification)

Exclusion Criteria:

  • Allergy to local anesthetics.
  • Local infection or inflammation at the site of the Block placement.
  • Presence of anatomical deformities in the spine
  • Coagulopathy or any bleeding disorder.
  • Pregnancy or breastfeeding women.
  • History of severe chronic pain syndrome

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：Control Group: Conventional Pain Management
This group will receive general anesthesia along with conventional pain management techniques, including opioid analgesics and other standard interventions typically used in postoperative nephrectomy care
实验性的：Intervention Group: Ultrasound-Guided Erector Spinae Plane Block
Patients in this group will receive general anesthesia in combination with the ultrasound-guided erector spinae plane (ESP) block, administered before the induction of anesthesia. The block targets the erector spinae muscle fascial plane, aiming to reduce postoperative pain and opioid consumption.
程序：Ultrasound-Guided Erector Spinae Plane (ESP) Block
The Ultrasound-Guided Erector Spinae Plane (ESP) Block is a regional anesthesia technique used to provide postoperative pain relief. In this study, the intervention involves the administration of a local anesthetic (0.25% bupivacaine) into the fascial plane between the erector spinae muscle and the transverse process of the vertebra using ultrasound guidance. The procedure is performed immediately before the induction of general anesthesia in patients undergoing open nephrectomy. The goal of the ESP block is to reduce postoperative pain, minimize opioid consumption, and improve recovery outcomes while maintaining hemodynamic stability. This intervention is compared to conventional pain management methods, which primarily rely on systemic opioids and other standard analgesics.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Visual Analogue Scale (VAS) for pain
大体时间：VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.

VAS score measures the intensity of pain, with 0 indicating no pain and 10 indicating the worst possible pain.

A lower VAS score means less pain and better pain management. A higher VAS score means more pain and poorer pain control.
VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.

次要结果测量

结果测量
措施说明
大体时间
Total Opioid Consumption
大体时间：Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.
Total opioid consumption will be tracked and recorded for each group during the first 24 hours post-surgery. The total amount of opioids used (in milligrams) will serve as an indicator of pain control effectiveness. A reduction in opioid consumption in the ESP block group, compared to the control group, would suggest that the ESP block is effective in reducing the need for opioids, thereby minimizing opioid-related side effects.
Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.
Peak Expiratory Flow Rate (PEFR)
大体时间：PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.
PEFR will be measured preoperatively and at multiple points postoperatively (1, 3, 6, and 24 hours) to assess respiratory function. This is particularly important in nephrectomy patients, as effective pain management helps promote better respiratory outcomes and reduce the risk of atelectasis or other complications. A higher PEFR value suggests better lung function and recovery.
PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.
Heart Rate (HR) Monitoring
大体时间：Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Heart rate (HR) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). This will help assess whether the ESP block maintains hemodynamic stability without causing significant fluctuations, such as tachycardia (increased heart rate), compared to conventional analgesia methods.
Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Systolic Blood Pressure (SBP) Monitoring in mmHg
大体时间：Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Systolic blood pressure (SBP) will be recorded preoperatively and at regular intervals (0, 1, 3, 6, 12, and 24 hours) postoperatively. The aim is to evaluate whether the ESP block offers better hemodynamic control by preventing significant blood pressure fluctuations compared to conventional analgesia methods.
Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Diastolic Blood Pressure (DBP) Monitoring in mmHg
大体时间：Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Diastolic blood pressure (DBP) will be measured preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). Monitoring DBP helps assess the stability of the cardiovascular system and ensure that the ESP block does not lead to significant hypotension or other adverse effects on circulation.
Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Mean Arterial Pressure (MAP) Monitoring in mmHg
大体时间：Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
Mean arterial pressure (MAP) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). MAP is a key indicator of perfusion pressure, ensuring adequate blood flow to organs. This outcome will evaluate whether the ESP block maintains stable MAP levels compared to conventional analgesic methods.
Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bangladesh Medical University

调查人员

  • 研究主任：AKM Akhtaruzzaman, MD、Bangladesh Medical University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月1日

初级完成 (估计的)

2026年6月30日

研究完成 (估计的)

2026年7月30日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年4月24日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月24日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BSMMU/2025/2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

研究数据/文件

  1. 研究协议
    信息标识符：pain.medicine@bsmmu.edu.bd

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅