Colicystitis
Conditions
Brief 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.
Interventions
DRUGLidocaine
Patients received intravenous lidocaine 1 mg/kg bolus followed by continuous infusion during laparoscopic cholecystectomy.
DRUGRemifentanil
Patients received intravenous remifentanil infusion during laparoscopic cholecystectomy.
Sponsors
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to first rescue analgesia | From the end of surgery until the first administration of rescue analgesia, up to 24 hours postoperatively. | The time from the end of surgery to the first administration of rescue analgesia (triggered by a Numeric Rating Scale score ≥4) will be recorded in minutes and compared between groups. |
| Postoperative Analgesic Requirement | First 24 hours postoperatively | Total amount of rescue analgesic medication administered (tramadol and paracetamol) within 24 hours after surgery will be recorded and compared between groups. |
| Recovery Profile | First 24 hours postoperatively | 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. |
| Postoperative nausea and vomiting | First 24 hours postoperatively | The incidence of postoperative nausea and vomiting (PONV) will be assessed during the first 24 hours after surgery and compared between groups. |
| Time to first mobilization | From the end of surgery until first mobilization, up to 24 hours postoperatively. | The time from the end of surgery to the patient's first mobilization will be recorded in hours and compared between groups. |
| spontaneous micturition | From the end of surgery until 24 hours postoperatively | The time interval between the completion of surgery and the first spontaneous urination after surgery |
| Passage of flatus or stool | Up to hospital discharge, an average of 2 days | Time interval between the completion of surgery and the first passage of flatus or stool, indicating the return of bowel function after surgery. |
Countries
Turkey (Türkiye)
Outcome results
None listed