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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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San Juan、プエルトリコ、00935
- 募集
- Puerto Rico Medical Center
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コンタクト：
- Luis Lojo-Sojo, MD
- 電話番号：787773535
- メール：luis.lojo@upr.edu
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主任研究者：
- Luis Lojo Sojo, MD
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副調査官：
- Norberto J Torres Lugo, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Morphine Miligram Equivalent (MME)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Luis Lojo Sojo, MD、University of Puerto Rico
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2406241594
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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