Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation
Efficacy of Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation: A Randomized Controlled Trial
The goal of this clinical trial is to find out whether a Pericapsular Nerve Group (PENG) block, a type of nerve block used to control pain, can reduce pain after surgery in adults with an acetabular (hip socket) fracture who are undergoing surgical repair. The study will also evaluate the safety of the PENG block.
The main questions this study aims to answer are:
Does a PENG block reduce pain after surgery? Does a PENG block reduce the need for opioid pain medications after surgery? Are there any side effects or complications related to the PENG block? Researchers will compare patients who receive a PENG block with patients who do not receive a PENG block to determine whether the block improves pain control after surgery.
Participants will:
Be randomly assigned to receive either a PENG block or no PENG block before surgery while under general anesthesia.
Undergo surgery to repair their acetabular fracture. Receive the same standard pain medications after surgery. Be asked to rate their pain at several time points after surgery using a standard pain scale.
Have their use of pain medications, recovery, and any side effects recorded during their hospital stay and follow-up.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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San Juan、波多黎各、00935
- 招聘中
- Puerto Rico Medical Center
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接触：
- Luis Lojo-Sojo, MD
- 电话号码：787773535
- 邮箱：luis.lojo@upr.edu
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首席研究员：
- Luis Lojo Sojo, MD
-
副研究员：
- Norberto J Torres Lugo, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patient age 18 years or older
- Acetabular Fracture amenable to surgery through the Kocher-Langenbeck approach
- Full weight-bearing capacity prior to the trauma
- Providing written informed consent
Exclusion Criteria:
- Age less than 18 years old
- Fracture pattern not amenable to surgery through Kocher-Langenbeck approach
- Lower extremity fracture ipsilateral to the acetabular fracture
- Any traumatic injury that requires surgical management by other surgical specialty
- Bilateral Acetabular Fractures
- Limited weight bearing capacity prior to the trauma
- Procedure performed under any anesthesia other than GETA
- Chronic opioid use
- History of Substance Abuse
- Allergies or history of adverse reactions to any of the drugs used in the
- Mental Disability
- History of Psychiatric disorders
学习计划
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PENG Block Group
This group includes participants who will receive the pericapsular nerve group (PENG) block after surgical intervention.
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PENG Block is a regional block technique well documented in the literature for certain orthopedic injuries and interventions.
However, the efficacy of this intervention on acetabular fracture fixation has not been well studied or addressed in previous literature.
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无干预：NO PENG Block Group
This group includes participants who will not receive the pericapsular nerve group (PENG) block after surgical intervention and will be considered our control group.
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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 |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
大体时间：From surgery to 48 hours after surgery (12 hour Intervals)
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The NPRS is an 11-point scale scored from 0-10, with " 0 " representing no pain and "10" being the most intense pain experienced.
Patients verbally select a value that is most in line with the intensity of pain that they have experienced at each time point under evaluation.
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From surgery to 48 hours after surgery (12 hour Intervals)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Morphine Miligram Equivalent (MME)
大体时间：From surgery to 48 hours after surgery (12 hour Intervals)
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MME is the total amount of an opioid drug converted to an equivalent strength of oral morphine.
This measure is used to track the consumption of opioids in a standardized, uniform way.
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From surgery to 48 hours after surgery (12 hour Intervals)
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Time to first opioid dose
大体时间：From surgery to 48 hours after surgery (Will quantify from surgery to time of administration)
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Will measure in minutes the time that patient spent without consuming opioids before requesting their first rescue therapy (opioid) dose.
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From surgery to 48 hours after surgery (Will quantify from surgery to time of administration)
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Postoperative Complications
大体时间：From surgery to 48 hours after surgery
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Inpatient complications are unforeseen medical issues that arise during a hospital stay, potentially extending recovery time or requiring additional treatment.
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From surgery to 48 hours after surgery
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合作者和调查者
调查人员
- 首席研究员：Luis Lojo Sojo, MD、University of Puerto Rico
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2406241594
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