ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty

NCT07336160 | Recruiting

• 1 other identifier: 2025-12/474
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled study is to investigate the effect of implementing a preoperative nutrition education and fasting protocol prepared in accordance with Enhanced Recovery After Surgery (ERAS) guidelines during the 24-hour preoperative period on postoperative hydration status and the incidence of nausea and vomiting in patients scheduled for total knee arthroplasty. Total knee arthroplasty is a commonly performed surgical procedure, particularly in older adults, and postoperative recovery may be negatively affected by surgical stress, anesthesia-related complications, dehydration, and postoperative nausea and vomiting. ERAS protocols emphasize the optimization of preoperative nutrition and hydration as key components to improve postoperative outcomes. In this study, patients undergoing elective total knee arthroplasty will be randomly assigned to an intervention group or a control group. Patients in the intervention group will receive ERAS-based preoperative nutrition education and a standardized fasting protocol during the 24 hours prior to surgery, while patients in the control group will receive routine standard care. Postoperative hydration status, nausea and vomiting severity, and fluid intake-output balance will be assessed and compared between the two groups. The findings of this study are expected to contribute to improving perioperative nursing care practices and enhancing patient recovery and comfort following total knee arthroplasty.

Conditions

Total Knee Arthroplasty; Postoperative Nausea and Vomiting

Keywords

Enhanced Recovery After Surgery; ERAS Protocol; Preoperative Nutrition; Fasting Protocol; Total Knee Replacement; Postoperative Hydration; Nausea and Vomiting; Perioperative Nursing Care

Outcome Measures

Primary Outcomes (2)

• Postoperative Thirst Discomfort

  Postoperative thirst discomfort assessed using the Surgical Thirst Discomfort Scale. The scale includes 6 items (dry mouth, dry lips, thick saliva, dry throat, bad taste in the mouth, desire to drink water), each rated from 0 to 2 (0 = not uncomfortable, 1 = slightly uncomfortable, 2 = very uncomfortable). Total score range: 0-12. Higher scores indicate greater thirst-related discomfort (worse outcome).

  Within the first 48 hours after surgery

• Postoperative Fluid Balance

  Postoperative hydration status assessed by fluid intake-output balance records.

  Within the first 48 hours after surgery

Secondary Outcomes (3)

• Postoperative Nausea and Vomiting Severity

  Within the first 48 hours after surgery

• Postoperative Nausea Intensity

  Within the first 48 hours after surgery

• Perioperative Fluid Balance

  From preoperative period to 48 hours postoperatively

Study Arms (2)

ERAS-Based Preoperative Nutrition and Fasting Protocol Group

EXPERIMENTAL

Participants receive ERAS-based preoperative nutrition education and an evidence-based fasting protocol during the 24 hours before total knee arthroplasty.

Behavioral: ERAS-Based Preoperative Nutrition Education and Fasting Protocol

Standard Care Group

ACTIVE COMPARATOR

Participants receive routine preoperative care according to standard clinical practice without ERAS-based nutrition education or fasting protocol.

Other: Standard Preoperative Care

Interventions

ERAS-Based Preoperative Nutrition Education and Fasting Protocol BEHAVIORAL

A structured preoperative nutrition education program and evidence-based fasting protocol developed in accordance with ERAS guidelines, implemented during the 24 hours prior to total knee arthroplasty.

ERAS-Based Preoperative Nutrition and Fasting Protocol Group

Standard Preoperative Care OTHER

Participants receive routine preoperative care according to standard institutional clinical practice without ERAS-based nutrition education or fasting protocol.

Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older.
• Patients scheduled for elective total knee arthroplasty.
• Patients expected to be hospitalized for at least 48 hours postoperatively.
• Ability to communicate verbally and provide informed consent.
• Patients with adequate cognitive and neurological capacity to understand study procedures.

You may not qualify if:

• Presence of any chronic disease requiring fluid restriction.
• Diagnosed cognitive impairment or psychiatric disorders affecting comprehension (e.g., Alzheimer's disease, dementia, psychotic disorders).
• Acute conditions causing dehydration in the preoperative period (e.g., vomiting, diarrhea, excessive fluid loss).
• Intraoperative complications requiring intensive care unit admission.
• Postoperative follow-up shorter than 48 hours due to early discharge or transfer to another clinic.

Sponsors & Collaborators

• Nermin Ocaktan: lead

Study Sites (1)

Acıbadem Health Group Atakent Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Nermin Ocaktan, PhD

  Acıbadem Mehmet Ali Aydınlar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nermin Ocaktan, PhD

CONTACT

+905337373306; nermin.ocaktan@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized into two parallel groups: an intervention group receiving ERAS-based preoperative nutrition education and fasting protocol, and a control group receiving standard care. Outcomes will be assessed preoperatively and postoperatively.

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 13, 2026
• Study Start: December 26, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)