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

NCT06885086 | Active Not Recruiting

• 1 other identifier: ERAS-LC-2025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Laparoscopic Cholecystectomy

Keywords

Pain Management; Cholecystectomy, Laparoscopic; Perioperative Care; Analgesia; Surgery

Outcome Measures

Primary Outcomes (1)

• Pain levels will be measured

  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 Outcomes (3)

• The length of hospital stay will be measured

  Time interval from hospitalisation to discharge (assessed up to 5 days).

• Total Additional Rate of Opioid Consumption During Hospital Stay

  Time interval from the postoperative period until discharge (From postoperative Day 0 to postoperative Day 3)

• Incidence of Early Postoperative Complications

  Intraoperative and postoperative time interval (postoperative Day 5)

Study Arms (2)

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

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

Interventions

Control group - 1 OTHER

Patient data will be collected retrospectively from the records.

Also known as: Retrospective group

Control group - 1

Observation group -2 DRUG

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.

Also known as: Prospective group

Observation group -2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead
• Toros University: collaborator

Study Sites (1)

Cukurova University

Sarıçam, Adana, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 33751409 BACKGROUND

• 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.

  PMID: 36820555 BACKGROUND

• 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.

  PMID: 28097305 BACKGROUND

• 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.

  PMID: 30426190 BACKGROUND

• Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

  PMID: 26509324 BACKGROUND

• 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.

  PMID: 21704871 BACKGROUND

• 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.

  PMID: 26827847 BACKGROUND

• 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.

  PMID: 20142348 BACKGROUND

• 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.

  PMID: 21463261 BACKGROUND

• 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.

  PMID: 24993439 BACKGROUND

• 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.

  PMID: 39390308 BACKGROUND

• 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.

  PMID: 33989641 BACKGROUND

• Freys JC, Bigalke SM, Mertes M, Lobo DN, Pogatzki-Zahn EM, Freys SM; 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.

  PMID: 38214556 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esma Gökçe

  Toros University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 20, 2025
• Study Start: June 13, 2025
• Primary Completion: March 16, 2026
• Study Completion: March 16, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)