ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNermin Ocaktan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ERAS-Based Preoperative Nutrition Education and Fasting Protocol
BehavioralA 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.
Standard Preoperative Care
Other interventionParticipants receive routine preoperative care according to standard institutional clinical practice without ERAS-based nutrition education or fasting protocol.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: ERAS-Based Preoperative Nutrition and Fasting Protocol GroupExperimental treatment 1 intervention
Group B: Standard Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Within the first 48 hours after surgery2
Postoperative Fluid Balance
Postoperative hydration status assessed by fluid intake-output balance records.
Time frame
Within the first 48 hours after surgerySecondary outcomes
1
Postoperative Nausea and Vomiting Severity
Severity of postoperative nausea and vomiting assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). The RINVR is an 8-item patient-reported scale. Each item is scored from 0 (no distress) to 4 (maximum distress), yielding a total score range of 0-32. Higher total scores indicate greater nausea/vomiting severity and distress (worse outcome).
Time frame
Within the first 48 hours after surgery2
Postoperative Nausea Intensity
Intensity of postoperative nausea assessed using the Numeric Nausea Rating Scale (NNRS). Participants rate their current nausea severity on a numeric scale from 0 to 10, where 0 indicates no nausea and 10 indicates the most severe nausea. Higher scores indicate greater nausea intensity (worse outcome).
Time frame
Within the first 48 hours after surgery3
Perioperative Fluid Balance
Perioperative fluid balance assessed as net fluid balance, calculated by subtracting total fluid output from total fluid intake using intake-output records.
Time frame
From preoperative period to 48 hours postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Nermin Ocaktan
Lead sponsor
Acibadem University
Sponsor institution
Source ClinicalTrials.gov