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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
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Miranda
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Caracas、Miranda、委内瑞拉、1040
- Hospital Universitario de Caracas
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intravenous lidocaine group
Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol.
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Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.
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安慰剂比较：Placebo group
Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions.
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Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.
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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 |
|---|---|---|
|
Postoperative pain intensity
大体时间：At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
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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.
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At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
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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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Total opioid comsumption
大体时间：From surgery completion through 24 hours after surgery.
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Total postoperative opioid requirement during the first 24 hours after surgery.
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From surgery completion through 24 hours after surgery.
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Post operative nausea and vomiting
大体时间：From surgery completion through 24 hours after surgery.
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Incidence of postoperative nausea and vomiting requiring treatment
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From surgery completion through 24 hours after surgery.
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Time to return of bowel function
大体时间：From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
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Time from surgery completion to first flatus or bowel movement.
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From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
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Lengh of hospital stay
大体时间：From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
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Time from surgery completion until hospital discharge.
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From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
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Plasma lidocaine concentration
大体时间：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
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Plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points to evaluate systemic exposure and pharmacokinetic profile.
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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
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合作者和调查者
调查人员
- 首席研究员：JOSEPH A VERAZA, MD、sociedad medica joseph veraza
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
- HUC-LIDO-APP-2024-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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