A Randomized Comparative Study of Opioid-Free Versus Opioid-Based Anesthesia in Laparoscopic Cholecystectomy Surgery

Postoperative pain remains a major clinical concern, affecting recovery, patient comfort, and hospital resource utilization. Traditionally, opioids have played a central role in intraoperative and postoperative pain management. However, opioid use is associated with several adverse effects such as respiratory depression, nausea, vomiting, sedation, ileus, tolerance, hyperalgesia, and dependency. These drawbacks have driven interest in alternative strategies that reduce or eliminate perioperative opioid exposure, particularly within the framework of Enhanced Recovery After Surgery (ERAS) protocols.

Opioid-Free Anesthesia (OFA) is a multimodal approach that omits opioids and instead utilizes a combination of non-opioid agents such as lidocaine, dexmedetomidine, ketamine, NSAIDs, and magnesium sulfate to provide analgesia, hemodynamic stability, and sedation. OFA aims to minimize opioid-related side effects while maintaining effective pain control and facilitating faster recovery.

This single-center, prospective, randomized controlled trial was designed to compare OFA using intravenous lidocaine and dexmedetomidine to standard general anesthesia with remifentanil in patients undergoing elective laparoscopic cholecystectomy. The primary aim was to assess the effect of OFA on postoperative pain scores and rescue analgesia requirement. Secondary outcomes included intraoperative hemodynamic parameters, postoperative nausea and vomiting (PONV), and recovery quality assessed via Modified Aldrete Scores.

A total of 101 adult patients, aged 18-65 years, classified as ASA I-II, were enrolled and randomized into two groups:

OFA Group: Received intravenous lidocaine (1.5 mg/kg bolus followed by infusion at 1.5 mg/kg/h) and dexmedetomidine (0.5 μg/kg loading dose followed by 0.5 μg/kg/h infusion).

RA Group (Remifentanil Group): Received standard anesthesia with remifentanil infusion (0.1-0.5 μg/kg/min), in combination with propofol and rocuronium.

Standard monitoring included non-invasive blood pressure, ECG, SpO₂, EtCO₂, and bispectral index (BIS). Intraoperative hemodynamic values (heart rate, systolic and diastolic blood pressure, EtCO₂) were recorded at 5-minute intervals. Postoperative pain was assessed using the Visual Analog Scale (VAS) at 10, 20, 30, and 60 minutes, and at 2, 12, and 24 hours. PONV incidence and the need for rescue antiemetics were also recorded. Recovery was evaluated using Modified Aldrete Scores at 0, 30, and 60 minutes post-extubation.

Statistical analysis was performed using R (v4.5.1). Normality was assessed via the Shapiro-Wilk test. Between-group comparisons used the independent t-test or Mann-Whitney U test for continuous variables and chi-square or Fisher's exact test for categorical data. Within-group comparisons of pre- and postoperative values used paired t-tests or Wilcoxon signed-rank tests as appropriate.

The study found that the OFA group had significantly lower postoperative VAS scores at all time points, reduced need for rescue analgesics, and lower incidence of PONV. Hemodynamic parameters such as heart rate and blood pressure were more stable intra- and postoperatively in the OFA group. Moreover, time to extubation was shorter and early recovery scores were higher among patients who received OFA.

These findings suggest that opioid-free anesthesia with lidocaine and dexmedetomidine provides superior outcomes in terms of postoperative pain control, recovery, and complication rates compared to opioid-based anesthesia with remifentanil. The results support the inclusion of OFA in clinical practice and ERAS protocols for laparoscopic cholecystectomy. Further multicenter studies with larger sample sizes and inclusion of different surgical procedures are warranted to generalize these findings.