ERAS (Enhanced Recovery After Surgery) and Multimodal Analgesia in Laparoscopic Cholecystectomy (ERAS)

March 16, 2026 updated by: Esma Gökçe, Cukurova University

The Impact of ERAS-Based Multimodal Pain Management on Clinical Outcomes in Laparoscopic Cholecystectomy: Ambispective Cohort Study

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group - 1
In the control group (previous standard care), no analgesic was administered intraoperatively. Postoperative analgesia was provided on an as-needed basis according to patients' pain levels. Accordingly, intravenous paracetamol (1 g, three times daily), intramuscular NSAIDs (twice daily), and intravenous opioids (tramadol; 50/100 mg once daily, based on patient weight) were prescribed pro re nata (PRN). These medications were not given routinely but only when a significant increase in pain was observed. The data required for the control group-including analgesic doses and information from data collection forms-will be obtained retrospectively from archive records.
Other: Control group - 1
Patient data will be collected retrospectively from the records.
Other Names:
  • Retrospective group
Observation group -2

Thirty minutes before anesthesia induction, 1 g of intravenous paracetamol is administered. During the intraoperative period, prior to wound closure, 800 mg of intravenous ibuprofen (diluted in 250 mL of normal saline) is administered. After trocar removal, 10 mL of 0.5% bupivacaine is infiltrated subcutaneously into the surgical wounds.

Postoperatively, patients receive oral paracetamol (1 g every 6 hours) and oral ibuprofen (400 mg every 8 hours). If the Visual Analog Scale (VAS) score exceeds 7, an additional opioid intervention is provided using oral Contramal (tramadol) (50/100 mg, based on patient weight).

For the observation group, a preoperative sociodemographic form is completed, and the VAS pain score is recorded at 2, 4, 8, 12, 18, and 24 hours postoperatively. Additionally, a clinical information and complication form is filled out before discharge.
Drug: Observation group -2
In the literature, multimodal analgesia strategies-as recommended by ERAS guidelines and supported by recent studies-are implemented. In the intraoperative period, patients receive paracetamol, NSAIDs, and local surgical wound infiltration analgesia. In the postoperative period, oral paracetamol and NSAIDs are routinely continued, with opioids administered as needed.
Other Names:
  • Prospective group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels will be measured
Time Frame: VAS score of pain at 2, 4, 8, 12, 18 and 24 hours in the recovery room and clinic
Patients' pain will be measured with Visual Analog Scale (VAS) (0 to 10, where 0 = no pain and 10 = the worst imaginable pain). A score of 1-3 represents mild pain, 4-6 represents moderate pain, and 7-10 represents severe and unbearable pain .
VAS score of pain at 2, 4, 8, 12, 18 and 24 hours in the recovery room and clinic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of hospital stay will be measured
Time Frame: Time interval from hospitalisation to discharge (assessed up to 5 days).
The discharge date and time of the patients will be recorded and the duration of their hospital stay will be determined.
Time interval from hospitalisation to discharge (assessed up to 5 days).
Total Additional Rate of Opioid Consumption During Hospital Stay
Time Frame: Time interval from the postoperative period until discharge (From postoperative Day 0 to postoperative Day 3)
Rescue (additional) opioids used in the postoperative period will be determined.
Time interval from the postoperative period until discharge (From postoperative Day 0 to postoperative Day 3)
Incidence of Early Postoperative Complications
Time Frame: Intraoperative and postoperative time interval (postoperative Day 5)
Intraoperative events, postoperative adverse events will be recorded. In addition, postoperative complications will be determined according to the Clavien-Dindo classification system.
Intraoperative and postoperative time interval (postoperative Day 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Collaborators

Toros University

Investigators

  • Principal Investigator: Esma Gökçe, Toros University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

March 16, 2026

Study Completion (Estimated)

March 16, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERAS-LC-2025

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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