NCT07312877

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colicystitis

Interventions

Type	Name	Description
DRUG	Lidocaine	Patients received intravenous lidocaine 1 mg/kg bolus followed by continuous infusion during laparoscopic cholecystectomy.
DRUG	Remifentanil	Patients received intravenous remifentanil infusion during laparoscopic cholecystectomy.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-11-25
• Completion: 2025-11-30
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Turkey (Türkiye)