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临床试验/NCT07765095
NCT07765095招募中不适用

Efficacy of Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation: A Randomized Controlled Trial

University of Puerto Rico1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

PENG Block Group

Experimental

This group includes participants who will receive the pericapsular nerve group (PENG) block after surgical intervention.

干预措施: Pericapsular nerve group (PENG) block (Procedure)

NO PENG Block Group

No Intervention

This group includes participants who will not receive the pericapsular nerve group (PENG) block after surgical intervention and will be considered our control group.

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: From surgery to 48 hours after surgery (12 hour Intervals)

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.

次要结局

  • Morphine Miligram Equivalent (MME)(From surgery to 48 hours after surgery (12 hour Intervals))
  • Time to first opioid dose(From surgery to 48 hours after surgery (Will quantify from surgery to time of administration))
  • Postoperative Complications(From surgery to 48 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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