ERAS (Enhanced Recovery After Surgery) and Multimodal Analgesia in Laparoscopic Cholecystectomy
NCT ID: NCT06885086
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2025-04-20
2025-08-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multimodal Analgesia for Cholecystectomy
NCT04788654
Postoperative Pain Management in Laparoscopic Cholecystectomies
NCT06326281
Enhanced Recovery After Cholecystectomy
NCT06339437
Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy
NCT06008002
Preoperative Pain Catastrophizing and Intraoperative Analgesia Consumption
NCT06838897
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Control group - 1
Patient data will be collected retrospectively from the records.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Control group - 1
Patient data will be collected retrospectively from the records.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Classified as ASA (American Society of Anesthesiologists) class I-II
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Toros University
OTHER
Cukurova University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Esma Gökçe
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Esma Gökçe
Role: PRINCIPAL_INVESTIGATOR
Toros University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cukurova University
Sarıçam, Adana, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Nechay T, Titkova S, Tyagunov A, Anurov M, Sazhin A. Modified enhanced recovery after surgery protocol in patients with acute cholecystitis: efficacy, safety and feasibility. Multicenter randomized control study. Updates Surg. 2021 Aug;73(4):1407-1417. doi: 10.1007/s13304-021-01031-5. Epub 2021 Mar 22.
Yu T, Zhao L, Zhao H, Fu H, Li J, Yu A. The enhanced recovery after surgery (ERAS) protocol in elderly patients with acute cholecystitis: A retrospective study. Medicine (Baltimore). 2023 Feb 10;102(6):e32942. doi: 10.1097/MD.0000000000032942.
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6.
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
Kehlet H, Andersen LO. Local infiltration analgesia in joint replacement: the evidence and recommendations for clinical practice. Acta Anaesthesiol Scand. 2011 Aug;55(7):778-84. doi: 10.1111/j.1399-6576.2011.02429.x. Epub 2011 Apr 4.
Joshi GP, Schug SA, Kehlet H. Procedure-specific pain management and outcome strategies. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):191-201. doi: 10.1016/j.bpa.2014.03.005. Epub 2014 May 9.
Nyundo M, Kayondo K, Gasakure M, Twagirumukiza JD, Gashegu J, Detry O. Implementation and outcomes of an enhanced recovery after surgery pathway for laparoscopic cholecystectomy in East and Central Africa: A prospective non-randomized controlled trial in Rwanda's Tertiary Teaching Hospital. World J Surg. 2025 Mar;49(3):605-614. doi: 10.1002/wjs.12371. Epub 2024 Oct 10.
Akbas S, Ozkan AS, Durak MA, Yologlu S. Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Neurochirurgie. 2021 Nov;67(6):533-539. doi: 10.1016/j.neuchi.2021.04.019. Epub 2021 May 11.
Freys JC, Bigalke SM, Mertes M, Lobo DN, Pogatzki-Zahn EM, Freys SM; on behalf of the PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Perioperative pain management for appendicectomy: A systematic review and Procedure-specific Postoperative Pain Management recommendations. Eur J Anaesthesiol. 2024 Mar 1;41(3):174-187. doi: 10.1097/EJA.0000000000001953. Epub 2024 Jan 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ERAS-LC-2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.