Clinical trial NCT06885086: ERAS (Enhanced Recovery After Surgery) and Multimodal Analgesia in Laparoscopic Cholecystectomy
Official title: The Impact of ERAS-Based Multimodal Pain Management on Clinical Outcomes in Laparoscopic Cholecystectomy: Ambispective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Laparoscopic Cholecystectomy
Keywords: Pain Management
Cholecystectomy, Laparoscopic
Perioperative Care
Analgesia
Surgery
Lead sponsor: Cukurova University
Sponsor class: OTHER
Collaborators: name: Toros University
First posted: 2025-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consisted of patients treated with the ERAS multimodal analgesia protocol between 2024 and 2025 who were treated with the routine pain management protocol of 2024. The sample size was also determined by power analysis.

Brief summary: This clinical study aims to evaluate the effects of multimodal analgesia management administered within an ERAS (Enhanced Recovery After Surgery) protocol on postoperative pain, length of hospital stay, early complications, and additional opioid requirements in patients undergoing laparoscopic cholecystectomy. The key questions addressed are:

* Does ERAS-based multimodal analgesia reduce postoperative pain?
* Does it shorten the hospital stay and lower early complication rates?
* What is its potential to reduce the need for additional opioids?

Participants:

* Prospective Group: Patients managed with an ERAS multimodal analgesia protocol (including paracetamol, NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), and local wound infiltration analgesics) between April and July 2025.
* Retrospective Group: Patient records from 2024 who were treated with a routine analgesia protocol.

Based on a power analysis, a minimum of 60 patients per group (total of 120 patients) will be included in the study (If the required sample size determined by the power analysis cannot be reached, the number of patients within the predefined time frame will be accepted as the sample).

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.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective laparoscopic cholecystectomy
* Classified as ASA (American Society of Anesthesiologists) class I-II

Exclusion Criteria:

* Patients with incomplete or insufficient medical records,
* Those undergoing concurrent major surgical procedures,
* Opioid users,
* ASA class III-IV patients,
* Those with hemorrhagic diathesis or coagulation disorders,
* A history of hypersensitivity to any medication used in this study
* Patients with peptic ulcer disease or gastrointestinal bleeding

Primary outcomes:
measure: Pain levels will be measured
timeFrame: VAS score of pain at 2, 4, 8, 12, 18 and 24 hours in the recovery room and clinic
Secondary outcomes:
measure: The length of hospital stay will be measured
timeFrame: Time interval from hospitalisation to discharge (assessed up to 5 days).
measure: Total Additional Rate of Opioid Consumption During Hospital Stay
timeFrame: Time interval from the postoperative period until discharge (From postoperative Day 0 to postoperative Day 3)
measure: Incidence of Early Postoperative Complications
timeFrame: Intraoperative and postoperative time interval (postoperative Day 5)
Other outcomes:
Locations:
city: Sarıçam
country: Turkey
facility: Cukurova University
state: Adana
Study officials:
affiliation: Toros University
name: Esma Gökçe
role: PRINCIPAL_INVESTIGATOR
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