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Recruiting NCT06784089

NCT06784089 Relationship Between Fracture Type and Preoperative Nutritional Status with Postoperative Pain

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Clinical Trial Summary
NCT ID NCT06784089
Status Recruiting
Phase
Sponsor Ankara Ataturk Sanatorium Training and Research Hospital
Condition Nutrition
Study Type OBSERVATIONAL
Enrollment 95 participants
Start Date 2025-01-15
Primary Completion 2025-12-30

Eligibility & Interventions

Sex All sexes
Min Age 65 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Geriatric Nutrition Risk Indexvisual analog scale

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 95 participants in total. It began in 2025-01-15 with a primary completion date of 2025-12-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The geriatric patient group is a population that should be considered differently than other age groups due to physiological characteristics that change with age. When literature data is examined, it is seen that patients over the age of 65 are evaluated differently in studies. The rapid aging of the general population causes more elderly patients to need surgery. However, malnutrition is a common comorbidity in surgical patients . In addition, chronic diseases, multiple drug addiction, low nutritional intake, decreased appetite and psychological conditions seen in geriatric patients are risk factors for the development of nutritional deficiencies . Therefore, it is important to specifically consider geriatric patients, who frequently have these risk factors, in terms of malnutrition and to evaluate the nutritional status of these patients before surgery. It is estimated that the prevalence of malnutrition in hospitalized geriatric patients varies between 30% and 60%, depending on the population studied and the assessment tools applied . Despite these high malnutrition rates, this issue has not received sufficient clinical attention. Furthermore, malnutrition is highly associated with the prognosis of elderly perioperative patients, which may lead to poor clinical outcomes, increased morbidity and mortality, complication rates, decreased quality of life, prolonged hospital stay, and increased hospital and healthcare costs. A number of different screening tools are currently available to assess nutritional status in the elderly. However, there is currently no gold standard. The Nutrition Risk Score 2002 (NRS2002) is a nutritional screening tool for adult inpatients, launched in 2002 by the European Society of Clinical Nutrition and Metabolism (ESPEN). The Mini Nutritional Assessment - Short Form (MNA-SF), recommended by the European Union, and the Geriatric Nutrition Risk Index (GNRI), which has recently been evaluated as a new screening tool, has been validated for the diagnosis of malnutrition and the prediction of clinical outcomes, and is based on objective measurements that do not require patient cooperation, and whose validity has been demonstrated in other studies for the prediction of short- and long-term outcomes. In addition, the Prognostic Nutrition Index (PNI) is an indicator used to assess the nutritional status of surgical patients, estimate the risk of surgery, and make prognostic judgments. Although it has been stated that all four nutritional screening tools mentioned above can be used as prognostic indicators in geriatric surgical patients, the relationship between these screening tools and postoperative pain, complications, and hospital stay in geriatric patients undergoing orthopedic hip surgery has not yet been evaluated. Hip fracture is a painful event that is frequently seen in older adults. Hip fractures are generally classified as femoral head fracture, femoral neck fracture, intertrochanteric fracture, and subtrochanteric fracture. Hip fracture is treated with proximal femoral nailing, partial hip replacement, and total hip replacement surgeries. Studies have reported that patients experience very high rates of moderate to severe pain following hip fracture surgery. This situation shows that the approach to pain management in hip surgery is still inadequate and that investigators need different perspectives on postoperative pain in these patients. It is known that hip fracture is associated with serious morbidity, mortality, and disability in the elderly. Inadequate pain management in these patients is associated with low motivation and has a high impact on functional recovery. Therefore, adequate pain management is important in patients with hip fractures to prevent mental and physical complications and to ensure appropriate compliance with rehabilitation. It is known that pain is affected by many factors such as biophysiological, biochemical, demographic, psychosocial, behavioral and moral variables and age. It is known that unmanaged postoperative pain will significantly affect cardiopulmonary and thromboembolic complications, morbidity and mortality, hospital discharge, quality of life and daily activities. In this context, determining the factors that predict acute pain will allow earlier intervention. Thus, short- and long-term morbidity, medication use, hospital stay and, accordingly, healthcare expenses will be reduced.This study aimed to evaluate the relationship between preoperative hip fracture type, surgery type, nutritional status and postoperative pain and prognosis (complications and hospital stay) in geriatric patients who will undergo hip surgery due to hip fracture. Secondly, it was aimed to determine which of the above-mentioned nutritional risk screening tools would be more appropriate in these patients and which nutritional risk screening tool could predict postoperative pain and prognosis in patients who will undergo hip surgery.

Eligibility Criteria

Inclusion Criteria: * Patients undergoing hip surgery * Patients with informed consent * Patients over the age of 65 * Patients undergoing surgery with spinal anesthesia * Patients evaluated in the ASA (American Society of Anesthesiologist) 1-2-3 category * Those with a body mass index (BMI) between 18-35 Exclusion Criteria: * Patients with ASA 4 and above * Patients under the age of 65 * Those with a BMI below 18 and above 35, * Patients with systemic inflammatory diseases, * Patients using continuous anti-inflammatory/analgesic drugs, * Patients with chronic pain before surgery, * Those with pathological fractures, * Multiple traumas * Those with end-stage disease (malignancy), * Severe renal failure, gastrointestinal ulceration or severe asthma that prevents the use of standard analgesia protocol * Patients who have previously had hip surgery on the same side * Patients who want to have surgery with general anesthesia * Patients who need general anesthesia in addition to spinal anesthesia * Those with a history of Pulmonary Thromboembolism

Contact & Investigator

Central Contact

Ferudun Ertan

✉ drfertan46@gmail.com

📞 +90 542 250 40 74

Frequently Asked Questions

Who can join the NCT06784089 clinical trial?

This trial is open to participants of all sexes, aged 65 Years or older, studying Nutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06784089 currently recruiting?

Yes, NCT06784089 is actively recruiting participants. Contact the research team at drfertan46@gmail.com for enrollment information.

Where is the NCT06784089 trial being conducted?

This trial is being conducted at Ankara, Turkey (Türkiye).

Who is sponsoring the NCT06784089 clinical trial?

NCT06784089 is sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. The trial plans to enroll 95 participants.

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