NCT06885086 | NOT YET RECRUITING | Laparoscopic Cholecystectomy

Detailed Description:

Laparoscopic cholecystectomy is regarded as the gold standard minimally invasive surgical method for treating gallstones and cholecystitis. This approach offers significant advantages over open surgery, including lower complication rates, shorter hospital stays, and faster postoperative recovery. Nevertheless, postoperative recovery and the risk of complications remain important concerns. The Enhanced Recovery After Surgery (ERAS) protocol is a comprehensive approach developed to accelerate postoperative recovery and reduce complications. It includes numerous components applied during the preoperative, intraoperative, and postoperative periods, all aiming to shorten recovery time and enhance patient comfort. A key element of ERAS protocols in surgical practice is pain management. Postoperative pain directly affects both the psychological and physiological recovery of surgical patients and is a critical clinical issue regarding treatment response and quality of life. Inadequate pain control may lead to delayed early mobilization, prolonged hospital stays, the development of chronic pain, and an increased risk of side effects associated with heightened opioid use. The concurrent use of multiple analgesic drugs or techniques, each targeting different pain mechanisms, has been advocated to reduce opioid-related side effects while enhancing analgesia through additive or synergistic effects. The primary goal is generally to reduce or entirely eliminate the use of potent opioids, which are associated with numerous disadvantages and unacceptable side effects. The American Pain Society (APS), in a guideline prepared by the American Society of Anesthesiologists (ASA), has recommended the implementation of multimodal analgesia in pain management strategies. The guideline strongly recommends, with high-quality evidence, that patients without contraindications receive paracetamol and/or nonsteroidal anti-inflammatory drugs (NSAIDs) as part of multimodal analgesia for postoperative pain management. It further indicates that paracetamol and NSAIDs possess different mechanisms of action, and their combination may be more effective than either drug alone. Additionally, the guideline advises clinicians to consider regional local anesthetic infiltration at the surgical site, supported by evidence of its efficacy (weak recommendation, moderate-quality evidence). The infiltration of long-acting local anesthetics in the surgical area has proven effective as a component of multimodal analgesia in various procedures. Overall, research on multimodal analgesia has encountered difficulties in yielding consistent results due to variability in the types of analgesics used, their dosages, and drug combinations. Since some of these techniques are relatively new while others are still under development, further research is needed to fully ascertain the synergistic effects of multimodal analgesia strategies. Moreover, there is limited literature regarding the clinical efficacy of combinations involving three or more analgesics. In light of these findings, there is a clear need for comprehensive research on multimodal analgesia strategies. Based on the recommendations of ERAS guidelines, this study was conceived to contribute to the literature by determining the synergistic analgesic efficacy achievable through the combination of different pain management mechanisms. Specifically, the efficacy of administering paracetamol and NSAIDs at appropriate times and dosages, along with the effectiveness of local anesthetic infiltration targeted at the surgical site for postoperative pain control, will be investigated. This study aims to evaluate the effects of ERAS protocol-based multimodal analgesia principles on postoperative pain, length of hospital stay, complications, and additional opioid requirements in patients undergoing laparoscopic cholecystectomy. Methods This non-randomized controlled study (an Ambispective Cohort Study) will be conducted on patients undergoing laparoscopic cholecystectomy in the general surgery clinic of a private hospital. The implementation of evidence-based ERAS protocols in the hospital has provided an opportunity to compare these protocols with the standard procedures performed previously. Thus, the study will involve prospectively observing patients managed according to the ERAS pain protocol (observation group) and retrospectively analyzing records of patients managed with the routine protocol before the implementation of ERAS (control group). The primary outcome is the evaluation of pain, while the secondary outcomes include hospital length of stay, early complication rates, and additional opioid requirements. The retrospective control group will consist of patients who received routine pain management in 2024, whereas the prospective observation group will consist of patients receiving the ERAS multimodal analgesia protocol between April and July 2025. No premedication is administered to participants for sedation. Patients are routinely monitored in the operating room using standard procedures, including heart rate (HR), non-invasive blood pressure (NIBP), electrocardiogram (ECG), peripheral oxygen saturation (SpO₂), and body temperature monitoring with an esophageal probe. A standardized general anesthesia protocol is administered to all patients by an experienced anesthesiologist. Intravenous patient-controlled analgesia (IV PCA) is not used. After post-anesthesia care unit (PACU) monitoring, patients are transferred to the clinical ward. These procedures apply to both groups.