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临床试验/NCT07312877
NCT07312877已完成不适用

Comparison of the Effectiveness of Intraoperative Intravenous Lidocaine and Intravenous Remifentanil in Postoperative Pain Management in Laparoscopic Cholecystectomy

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
1
主要终点
Postoperative Pain Score (NRS)

研究概览

简要总结

This study aims to compare the effects of intraoperative intravenous lidocaine and intravenous remifentanil on postoperative pain management in patients undergoing laparoscopic cholecystectomy under general anesthesia. Although laparoscopic procedures are minimally invasive, patients frequently experience postoperative pain. Multimodal analgesia techniques are recommended to optimize pain control and recovery while minimizing opioid-related adverse effects.

In this prospective observational study, adult patients (ASA I-II) aged over 18 years who provided written informed consent were included. Standard intraoperative monitoring was performed. Anesthesia induction consisted of fentanyl, lidocaine, propofol, and rocuronium, with maintenance using sevoflurane. Hemodynamic parameters were recorded throughout the procedure. For postoperative analgesia, intravenous paracetamol and tramadol were administered before the end of anesthesia.

The primary objective is to evaluate whether intravenous lidocaine provides postoperative analgesic efficacy and recovery quality comparable to remifentanil, and to determine its potential role as an opioid-sparing alternative in laparoscopic cholecystectomy.

详细描述

This prospective observational study was designed to compare the effects of intraoperative intravenous lidocaine and intravenous remifentanil on postoperative pain control, hemodynamic stability, and recovery quality in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Although laparoscopic surgery is minimally invasive, patients frequently experience moderate to severe postoperative pain, which can delay recovery and discharge. Multimodal analgesia strategies have been developed to improve postoperative comfort while minimizing the adverse effects of opioids such as respiratory depression, nausea, and delayed recovery.

The study was conducted following approval from the institutional ethics committee, and written informed consent was obtained from all participants. Patients aged over 18 years with an ASA physical status of I-II were included. Standard monitoring (DII and V5 ECG, non-invasive blood pressure, and pulse oximetry) was applied upon arrival in the operating room. General anesthesia was induced with fentanyl (1-2 mcg/kg), lidocaine (1 mg/kg), propofol (2-2.5 mg/kg), and rocuronium (0.6 mg/kg). Anesthesia was maintained with sevoflurane in oxygen/air mixture.

Hemodynamic parameters, including heart rate, systolic, diastolic, and mean arterial pressures, and oxygen saturation (SpO₂), were recorded at baseline and at defined intraoperative intervals. Twenty minutes before the end of the procedure, intravenous paracetamol (15 mg/kg) and tramadol hydrochloride (10 mg/kg) were administered for postoperative analgesia. After emergence from anesthesia, patients were transferred to the post-anesthesia care unit (PACU) and then to the ward once the Aldrete recovery score reached 9.

Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) at regular intervals for 24 hours. When NRS > 4, rescue analgesia was administered according to the institutional protocol. The collected data were analyzed to compare intraoperative hemodynamic stability, depth of anesthesia, postoperative recovery characteristics, and analgesic requirements between the lidocaine and remifentanil groups.

The primary hypothesis of this study is that intravenous lidocaine can provide comparable postoperative analgesia to remifentanil, with potential benefits such as improved hemodynamic stability, faster recovery, and fewer opioid-related side effects. The findings may support the use of lidocaine as an effective opioid-sparing alternative in multimodal analgesia protocols for laparoscopic cholecystectomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over 18 years of age
  • •ASA physical status I-II
  • •Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • •Provided written and verbal informed consent

排除标准

  • •Allergy or contraindication to lidocaine, remifentanil, or study drugs
  • •Severe cardiovascular, hepatic, or renal disease
  • •Pregnancy or lactation
  • •Conversion from laparoscopic to open cholecystectomy
  • •Refusal to participate

研究组 & 干预措施

Lidocaine Group

Patients received IV lidocaine (1 mg/kg bolus + infusion) during laparoscopic cholecystectomy

干预措施: Lidocaine (Drug)

Remifentanil Group

Patients received IV remifentanil infusion during laparoscopic cholecystectomy

干预措施: Remifentanil (Drug)

结局指标

主要结局

Postoperative Pain Score (NRS)

时间窗: Within 24 hours after surgery

Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Pain scores at rest will be assessed at 30 minutes and at 2, 6, 12, and 24 hours postoperatively. The comparison between the lidocaine and remifentanil groups will determine the effect of intraoperative intravenous lidocaine versus remifentanil on postoperative analgesia.

次要结局

  • time to first rescue analgesia(From the end of surgery until the first administration of rescue analgesia, up to 24 hours postoperatively.)
  • Recovery Profile(First 24 hours postoperatively)
  • Postoperative nausea and vomiting(First 24 hours postoperatively)
  • Time to first mobilization(From the end of surgery until first mobilization, up to 24 hours postoperatively.)
  • spontaneous micturition(From the end of surgery until 24 hours postoperatively)
  • Passage of flatus or stool(Up to hospital discharge, an average of 2 days)
  • Postoperative Analgesic Requirement(First 24 hours postoperatively)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilsu GÜNDÜZ

resident doctor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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