An interventional study of ERAS-Based Preoperative Nutrition Education and Fasting Protocol and Standard Preoperative Care in Total Knee Arthroplasty and Postoperative Nausea and Vomiting, sponsored by Nermin Ocaktan. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Nermin Ocaktan · Not applicable, Interventional, and Treatment
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.
This randomized controlled trial is designed to evaluate the effect of ERAS protocol-based preoperative nutrition education and fasting management on postoperative hydration status and nausea-vomiting outcomes in patients undergoing elective total knee arthroplasty.
Total knee arthroplasty is an effective and frequently performed surgical intervention, particularly among older adults with degenerative joint disease. However, perioperative stress, prolonged fasting, and anesthesia-related factors may adversely affect postoperative recovery, leading to dehydration, nausea, and vomiting. Optimizing perioperative care through evidence-based ERAS protocols is therefore essential to improve patient outcomes.
ERAS protocols promote a multidisciplinary approach aimed at reducing surgical stress and accelerating postoperative recovery. One of the core components of ERAS is the optimization of preoperative nutrition and hydration. According to evidence-based guidelines, solid foods may be consumed up to 6 hours and clear liquids up to 2 hours prior to elective surgery. This approach reduces unnecessary prolonged fasting, prevents dehydration and insulin resistance, and improves postoperative comfort without increasing anesthesia-related risks.
The study will be conducted in the orthopedic clinic of Acıbadem Altunizade Hospital. Eligible patients scheduled for elective total knee arthroplasty will be recruited and randomly assigned to either the intervention or control group using a simple randomization method. Written informed consent will be obtained from all participants prior to enrollment.
Patients in the intervention group will receive an ERAS-based preoperative nutrition education leaflet and will be instructed to follow the standardized nutrition and fasting protocol during the 24-hour preoperative period. Patients in the control group will receive routine standard preoperative care as applied in the clinic.
Data collection will include demographic and clinical characteristics, postoperative hydration status, nausea and vomiting frequency and severity, and fluid intake-output monitoring. The following validated instruments will be used: the Surgical Thirst Discomfort Scale, the Rhodes Index of Nausea, Vomiting and Retching, a numeric nausea rating scale, and fluid balance monitoring forms.
Postoperative outcomes will be assessed for both groups, including hydration status, nausea and vomiting incidence, and fluid intake-output balance. Statistical analyses will be performed using SPSS software. Appropriate parametric or non-parametric tests will be applied based on data distribution, with a significance level set at p \< 0.05.
This study aims to provide evidence on the effectiveness of ERAS-based preoperative nutrition education and fasting protocols in improving postoperative hydration and reducing nausea and vomiting, thereby supporting the development of structured, evidence-based nursing interventions in perioperative care.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's planned enrollment of 72 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Nermin Ocaktan is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants receive routine preoperative care according to standard clinical practice without ERAS-based nutrition education or fasting protocol.
Other: Standard Preoperative Care
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.
Participants receive routine preoperative care according to standard institutional clinical practice without ERAS-based nutrition education or fasting protocol.
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 surgery
Postoperative Fluid Balance
Postoperative hydration status assessed by fluid intake-output balance records.
Time frame: Within the first 48 hours after surgery
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 surgery
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 surgery
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 postoperatively
Plan to share: No
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Started Dec 2025 (actual). Primary completion is estimated for Aug 2026, 8 months after the start.
Of 181 non-industry interventional studies with no phase under Postoperative Nausea and Vomiting, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 8 months is below that.
Counting every sponsor, half of 181 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
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