Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
Impact of Preemptive Analgesia on Postoperative Pain in Patients Undergoing Orthognathic Surgery: A Randomized Controlled Trial.
This randomized controlled clinical trial evaluates the effect of preemptive analgesia on postoperative pain outcomes in adult patients undergoing orthognathic surgery. Participants scheduled for bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia will be randomized to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving standard postoperative analgesia without preoperative medication.
The study aims to determine whether the administration of pre-surgical analgesics reduces postoperative pain intensity and analgesic requirements during the early postoperative period. Pain will be assessed using a standardized pain scale at multiple time points following surgery, and secondary outcomes will include postoperative analgesic consumption and patient satisfaction with pain control.
This investigation seeks to contribute evidence supporting multimodal analgesic strategies and improved postoperative pain management in patients undergoing orthognathic surgery.
調査の概要
詳細な説明
Effective management of postoperative pain remains an important component of perioperative care in patients undergoing orthognathic surgery. Procedures such as bilateral sagittal split osteotomy and Le Fort I osteotomy are associated with significant postoperative discomfort due to extensive manipulation of osseous and soft tissue structures. Preemptive analgesia, defined as the administration of analgesic medication prior to surgical injury, has been proposed as a strategy to attenuate central sensitization and reduce postoperative pain intensity.
This study is designed as a participant-blinded, randomized controlled clinical trial conducted in the operating room at the Administration of Medical Services in Puerto Rico (ASEM). Adult patients between 21 and 65 years of age with American Society of Anesthesiologists (ASA) physical status I or II who are scheduled to undergo orthognathic surgery will be invited to participate following informed consent. A total of 72 participants will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving no preoperative analgesic intervention.
Participants in the intervention groups will receive either acetaminophen 1 g intravenously or ibuprofen 600 mg intravenously approximately 30 minutes before surgical incision, with a second dose administered near the end of the procedure according to the medication half-life. The control group will receive no pre-surgical analgesic administration and will follow the institution's standard postoperative pain management protocol.
Postoperative pain intensity will be measured using a validated pain scale at predetermined intervals during the postoperative period. Additional outcomes include postoperative analgesic requirements and patient satisfaction with pain control. By comparing two commonly used intravenous analgesic medications with standard care, this study aims to evaluate the effectiveness of preemptive analgesic strategies in improving postoperative pain outcomes and reducing analgesic consumption following orthognathic surgery.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Dennys Rivera Pérez, MD
- 電話番号：1920-1921 7877582525
- メール：dennys.rivera@upr.edu
研究連絡先のバックアップ
- 名前：Alvara J Horta Caicedo, DMD
- 電話番号：1-678-394-7721
- メール：alvaro.horta@upr.edu
研究場所
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San Juan、プエルトリコ、00936
- Administración de Servicios Médicos (ASEM)
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コンタクト：
- Dennys Rivera Pérez, MD
- 電話番号：1920-1921 7877582525
- メール：dennys.rivera@upr.edu
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コンタクト：
- Alvara J Horta Caicedo, DMD
- 電話番号：1-678-394-7721
- メール：alvaro.horta@upr.edu
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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:
- Adults aged 21 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled to undergo orthognathic surgery including bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia.
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Known allergy or intolerance to acetaminophen, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- Renal dysfunction, defined as estimated glomerular filtration rate <60 mL/min/1.73 m².
- Hepatic dysfunction, defined as liver enzyme levels greater than twice the upper limit of normal.
- History of bleeding disorders or coagulopathy.
- Active or recent peptic ulcer disease.
- Current use of recreational drugs, including cannabis, that in the judgment of the investigators could interfere with anesthesia management, postoperative pain assessment, or study outcomes.
- Any medical condition that, in the judgment of the investigators, would make participation unsafe or interfere with study participation.
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：トリプル
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：Intravenous Acetaminophen
Participants randomized to this arm will receive acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the surgical procedure according to the medication half-life.
Postoperative pain outcomes will be compared with the other study groups.
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Acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the surgical procedure according to the medication half-life.
他の名前：
|
|
実験的：Intravenous Ibuprofen
Participants randomized to this arm will receive ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the procedure according to the medication half-life.
Postoperative pain outcomes will be compared with the other study groups.
|
Ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the surgical procedure according to the medication half-life.
他の名前：
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介入なし：Standard Care Control
Participants randomized to this arm will not receive preoperative analgesic medication.
Postoperative pain management will follow the institution's standard care protocol after completion of the surgical procedure.
Outcomes will be compared with participants receiving preemptive intravenous analgesic interventions.
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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 |
|---|---|---|
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Postoperative Pain Intensity
時間枠：1 hour, 4 hours, and 24 hours after surgery
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Postoperative pain intensity measured using a validated pain scale (Visual Analog Scale, 0-10) in patients undergoing orthognathic surgery.
Pain scores will be recorded and compared between the acetaminophen, ibuprofen, and control groups.
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1 hour, 4 hours, and 24 hours after surgery
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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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Postoperative Analgesic Consumption
時間枠：Within 24 hours after surgery
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Total amount of rescue analgesic medications administered during the postoperative period will be recorded and compared between study groups.
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Within 24 hours after surgery
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Patient Satisfaction with Pain Management
時間枠：24 hours after surgery
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Patient satisfaction with postoperative pain control measured using the Spanish version of the Pain Treatment Satisfaction Scale (PTSS).
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24 hours after surgery
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Cillo JE Jr, Dattilo DJ. Pre-emptive analgesia with pregabalin and celecoxib decreases postsurgical pain following maxillomandibular advancement surgery: a randomized controlled clinical trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1909-14. doi: 10.1016/j.joms.2014.05.014. Epub 2014 May 27.
- Alyahya A, Aldubayan A, Swennen GRJ, Al-Moraissi E. Effectiveness of different protocols to reduce postoperative pain following orthognathic surgery: A systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Sep;60(7):e1-e10. doi: 10.1016/j.bjoms.2022.03.013. Epub 2022 Apr 23.
- Xuan C, Yan W, Wang D, Li C, Ma H, Mueller A, Chin V, Houle TT, Wang J. Efficacy of preemptive analgesia treatments for the management of postoperative pain: a network meta-analysis. Br J Anaesth. 2022 Dec;129(6):946-958. doi: 10.1016/j.bja.2022.08.038. Epub 2022 Oct 26.
研究記録日
主要日程の研究
研究開始 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2603555595
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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