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

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.

Study Overview

• Status: Completed
• Conditions: Colicystitis
• Intervention / Treatment: Drug: Lidocaine; Drug: Remifentanil

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.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34384
      • Prof. Dr. Cemil Taşcıoğlu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (ASA I-II) undergoing elective laparoscopic cholecystectomy under general anesthesia at Prof. Dr. Cemil Taşçıoğlu City Hospital.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lidocaine Group; Patients received IV lidocaine (1 mg/kg bolus + infusion) during laparoscopic cholecystectomy	Drug: Lidocaine; Patients received intravenous lidocaine 1 mg/kg bolus followed by continuous infusion during laparoscopic cholecystectomy.
Remifentanil Group; Patients received IV remifentanil infusion during laparoscopic cholecystectomy	Drug: Remifentanil; Patients received intravenous remifentanil infusion during laparoscopic cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Score (NRS)	Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Pain scores will be recorded at rest at 1, 6, 12, and 24 hours after surgery. The comparison between the lidocaine and remifentanil groups will determine the effect of intraoperative intravenous lidocaine versus remifentanil on postoperative analgesia.	Within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Changes in heart rate will be recorded at baseline, during pneumoperitoneum, and throughout surgery to evaluate intraoperative hemodynamic stability between groups.	Intraoperative period
Mean Arterial Pressure	Changes in mean arterial blood pressure will be recorded at baseline, during pneumoperitoneum, and throughout surgery to evaluate intraoperative hemodynamic stability between groups.	Intraoperative period
Systolic Blood Pressure	Changes in systolic blood pressure will be recorded at baseline, during pneumoperitoneum, and throughout surgery to evaluate intraoperative hemodynamic stability between groups.	Intraoperative period
Diastolic blood Pressure	Changes in diastolic blood pressure will be recorded at baseline, during pneumoperitoneum, and throughout surgery to evaluate intraoperative hemodynamic stability between groups.	Intraoperative period
Recovery Profile	Time to reach an Aldrete score ≥9 (range 0-10, with higher scores indicating better recovery) will be measured to evaluate the effect of intraoperative lidocaine versus remifentanil on recovery characteristics.	Immediate postoperative period
Postoperative Analgesic Requirement	Total amount of rescue analgesic medication administered (tramadol and paracetamol) within 24 hours after surgery will be recorded and compared between groups.	First 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Piperidines; Propionates; Remifentanil; Lidocaine
• Other Study ID Numbers: NG269436444.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No