Intraoperative Intravenous Lidocaine for Pain After Laparoscopic Appendectomy (LIDO-APP)
Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial
調査の概要
詳細な説明
Postoperative pain following laparoscopic appendectomy remains an important clinical concern despite advances in multimodal analgesia. Intravenous lidocaine has been proposed as an effective adjunct because of its analgesic, anti-inflammatory, and antihyperalgesic properties, but evidence in laparoscopic appendectomy remains limited.
This prospective, randomized, double-blind, placebo-controlled trial compared continuous intraoperative intravenous lidocaine infusion with placebo in patients undergoing laparoscopic appendectomy under standardized general anesthesia. Patients were randomly allocated to receive either lidocaine or placebo according to the study protocol.
The primary outcome was postoperative pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included opioid requirements, postoperative nausea and vomiting, return of bowel function, length of hospital stay, incidence of adverse events, and perioperative plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points.
The study aimed to determine the clinical efficacy and safety of intravenous lidocaine infusion as part of multimodal perioperative analgesia for laparoscopic appendectomy and to correlate analgesic effects with measured plasma lidocaine concentrations.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Miranda
-
Caracas、Miranda、ベネズエラ、1040
- Hospital Universitario de Caracas
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 to 45 years.
- ASA physical status I or II.
- Scheduled for laparoscopic appendectomy under general anesthesia.
- Able to provide written informed consent.
Exclusion Criteria:
- History of cardiac conduction disorders or documented arrhythmias.
- Hepatic insufficiency.
- Renal insufficiency.
- Chronic or long-term opioid therapy.
- Known or suspected hypersensitivity to amide-type local anesthetics.
- Hemodynamic instability at the time of admission to the operating room.
- Body mass index greater than 35 kg/m².
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intravenous lidocaine group
Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol.
|
Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.
|
|
プラセボコンパレーター：Placebo group
Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions.
|
Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.
|
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 |
|---|---|---|
|
Postoperative pain intensity
時間枠：At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
|
Postoperative pain intensity assessed using the Visual Analogue Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Lower scores indicate better analgesic efficacy.
|
At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total opioid comsumption
時間枠：From surgery completion through 24 hours after surgery.
|
Total postoperative opioid requirement during the first 24 hours after surgery.
|
From surgery completion through 24 hours after surgery.
|
|
Post operative nausea and vomiting
時間枠：From surgery completion through 24 hours after surgery.
|
Incidence of postoperative nausea and vomiting requiring treatment
|
From surgery completion through 24 hours after surgery.
|
|
Time to return of bowel function
時間枠：From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
|
Time from surgery completion to first flatus or bowel movement.
|
From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
|
|
Lengh of hospital stay
時間枠：From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
|
Time from surgery completion until hospital discharge.
|
From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
|
|
Plasma lidocaine concentration
時間枠：From baseline through 1 hour after admission to the post-anesthesia care unit (PACU), with plasma lidocaine concentrations assessed at baseline, 30 minutes after study drug infusion initiation, 90 minutes after study drug infusion initiation, and 1 hour
|
Plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points to evaluate systemic exposure and pharmacokinetic profile.
|
From baseline through 1 hour after admission to the post-anesthesia care unit (PACU), with plasma lidocaine concentrations assessed at baseline, 30 minutes after study drug infusion initiation, 90 minutes after study drug infusion initiation, and 1 hour
|
協力者と研究者
捜査官
- 主任研究者：JOSEPH A VERAZA, MD、sociedad medica joseph veraza
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- HUC-LIDO-APP-2024-001
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。