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IRCT20210222050463N13 IRCT 2026-11-01 Ahvaz University of Medical Sciences Comparing ERAS with a Carbohydrate Drink and Traditional Fasting in Knee Replacement Surgery A Comparison of the ERAS Protocol Including Oral Carbohydrate Supplementation versus the Traditional NPO Approach in Patients Undergoing Total Knee Arthroplasty 2026-11-08 anticipated 78 Recruiting https://irct.ir/trial/93897 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Method of randomization: Block randomization with variable block sizes of 4 and 6. Unit of randomization: Individual patients. Randomization strata: None (no stratified randomization was used). Tools used in randomization: The random allocation sequence was generated using Sealed Envelope, a secure online randomization service designed for clinical trials. The software was set to produce permuted blocks of sizes 4 and 6. How the random sequence was built: The principal investigator configured the Sealed Envelope system with two treatment arms (ERAS with carbohydrate supplementation and traditional NPO) and variable block sizes (4 and 6). The software then generated a randomization list with sequential subject numbers. The list was exported and used to prepare the allocation envelopes. Allocation concealment: Sequentially numbered, opaque, sealed envelopes were prepared by an independent person not involved in patient enrollment. The envelopes were prepared according to the randomization list generated by Sealed Envelope. Each envelope was opened only after the patient was confirmed eligible and had provided written informed consent. The independent person kept the randomization list confidential until the end of the study, Blinding description: Due to the nature of the intervention (oral carbohydrate drink versus traditional fasting), participants could not be blinded to their group allocation. The care providers and the principal investigator were also aware of the group assignments because they were responsible for administering the intervention and monitoring patients. However, the outcome assessor responsible for collecting postoperative pain scores (VAS), opioid consumption (MME), and functional assessments was blinded to group allocation. All outcome measurements were performed by a trained assessor who was unaware of whether the patient belonged to the ERAS or NPO group. Data analysis was performed on coded data without group identifiers, so the data analyst was also blinded to group allocation. N/A Knee osteoarthritis (gonarthrosis) in patients undergoing total knee arthroplasty. Intervention 1: Intervention group: Enhanced Recovery After Surgery protocol with preoperative oral carbohydrate supplementation. Patients receive a clear carbohydrate-rich drink (400 mL of 12.5% carbohydrate solution) 2 hours before induction of anesthesia. The protocol also includes preoperative patient education, multimodal opioid-sparing analgesia, perioperative local infiltration analgesia, goal-directed fluid therapy, normothermia maintenance, and early postoperative mobilization and oral intake. Intervention 2: Control group: Traditional nil per os fasting and conventional perioperative care. Patients fast from midnight before surgery (nothing by mouth) and receive standard perioperative care without preoperative carbohydrate supplementation or Enhanced Recovery After Surgery protocol components. No - There is not a plan to make this available Justification or reason for not sharing IPD is The deidentified individual participant data will not be shared because the study protocol and informed consent form do not include permission for public data sharing. Participant confidentiality is of utmost importance, and the data will be used solely for the purposes of this study.
public Nooshin Sarvi-Sarmeydani
School of Paramedicine, Anesthesiology Department, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 0011 nooshinsarvi9192@gmail.com Ahvaz University of Medical Sciences scientific Nooshin Sarvi-Sarmeydani
School of Paramedicine, Anesthesiology Department, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 0011 nooshinsarvi9192@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Adult patients (≥18 years old) scheduled for elective total knee arthroplasty. Patients physically fit for elective surgery according to the attending physician and classified as ASA I–III. Willingness to provide written informed consent and ability to cooperate with data collection procedures. Ability to orally intake and tolerate oral fluids. 18 years no limit Both Patients undergoing emergency surgery or surgery related to knee fractures. Patients with uncontrolled diabetes, severe cardiovascular, renal, or hepatic diseases that may interfere with the ERAS protocol. Patients with gastrointestinal disorders or malabsorption that prevent oral intake of carbohydrate solution. History of allergy or adverse reaction to any component of the carbohydrate solution. Inability or unwillingness to complete the study procedures or postoperative follow-up. M17.9 Osteoarthritis of knee, unspecified Other Other Intervention group: Enhanced Recovery After Surgery protocol with preoperative oral carbohydrate supplementation. Patients receive a clear carbohydrate-rich drink (400 mL of 12.5% carbohydrate solution) 2 hours before induction of anesthesia. The protocol also includes preoperative patient education, multimodal opioid-sparing analgesia, perioperative local infiltration analgesia, goal-directed fluid therapy, normothermia maintenance, and early postoperative mobilization and oral intake. Control group: Traditional nil per os fasting and conventional perioperative care. Patients fast from midnight before surgery (nothing by mouth) and receive standard perioperative care without preoperative carbohydrate supplementation or Enhanced Recovery After Surgery protocol components. Postoperative pain intensity. Timepoint: Before intervention (baseline) and at 6, 12, 24, 48, and 72 hours after surgery. Method of measurement: Visual Analogue Scale, a 10-centimeter horizontal line with endpoints labeled "no pain" (0) and "worst imaginable pain" (10), administered by a trained outcome assessor. Postoperative opioid analgesic consumption. Timepoint: During the first 72 hours after surgery. Method of measurement: Recording all administered opioid analgesics including morphine, fentanyl, and tramadol from medication administration records, and converting them to Morphine Milligram Equivalents for standardized comparison. Postoperative hospital length of stay. Timepoint: From the day of surgery until hospital discharge. Method of measurement: Review of medical records and calculation of the number of days hospitalized postoperatively. Time to first mobilization and physiotherapy performance. Timepoint: During the first 72 hours after surgery. Method of measurement: Standardized Enhanced Recovery After Surgery protocol checklist and physiotherapy assessment. Ahvaz University of Medical Sciences Approved 2026-05-16 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Vice Chancellery for Research and Technology, 1st Floor, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)