Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial evaluated whether intraoperative intravenous lidocaine infusion improves postoperative analgesia and recovery in patients undergoing laparoscopic appendectomy. The primary objective was to assess postoperative pain intensity and opioid consumption. Secondary outcomes included postoperative nausea and vomiting, time to bowel function recovery, length of hospital stay, plasma lidocaine concentrations, and adverse events.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, anesthesia providers, investigators, and outcome assessors were blinded to treatment allocation throughout the study. Intravenous lidocaine and placebo solutions were prepared in identical syringes by personnel not involved in patient management or outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Postoperative pain intensity
时间窗: 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.
次要结局
- Total opioid comsumption(From surgery completion through 24 hours after surgery.)
- Post operative nausea and vomiting(From surgery completion through 24 hours after surgery.)
- Time to return of bowel function(From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.)
- Lengh of hospital stay(From surgery completion until hospital discharge (anticipated within 72 hours after surgery).)
- Plasma lidocaine concentration(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)
研究者
Joseph Alejandro Veraza Almeida
Principal Investigator
Hospital Universitario de Caracas