NutritionNCT06784089
Relationship Between Fracture Type and Preoperative Nutritional Status With Postoperative Pain
An observational study of Nutrition and Postoperative Pain, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutrition, Postoperative Pain, Hip Fracture
- What is being tested?
- Geriatric Nutrition Risk Index and visual analog scale
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who are over the age of 65 and who will undergo surgery due to hip fracture
Who may be able to join
- 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
Who cannot join
- 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,
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, 6280
About this study
Official title: Relationship Between Fracture Type and Preoperative Nutritional Status With Postoperative Pain and Prognosis in Geriatric Hip Surgery
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.
Read the detailed description
Purpose/Hypothesis:
H0: There is no relationship between fracture type and preoperative nutritional status and postoperative pain and prognosis in geriatric hip surgery.
H1: There is a relationship between fracture type and preoperative nutritional status and postoperative pain and prognosis in geriatric hip surgery.
Material-Method:
This study will be conducted in accordance with the Declaration of Helsinki and will be conducted at the SBÜ Ankara Atatürk Sanatoryum Education and Research Hospital after receiving approval from the relevant units and ethics committee. The study was designed as a single-center prospective observational study.
Patients who are over the age of 65 and who will undergo surgery due to hip fracture and who agree to participate in this observational study and sign the informed consent form will be prospectively recorded using the patient follow-up forms investigators have prepared.
The standard anesthesia and analgesia protocol that investigators routinely apply to patients will be applied throughout the surgery. If the patient has pain after the surgery, the patient will not wait and the necessary analgesic treatment will be given to the patient. The patients' preoperative routine blood tests, age, height, body weight, BMI, gender, diagnoses, American Society of Anesthesiologists (ASA) physical status score, Charlson Comorbidity Index (CCI), fracture type (femoral head fracture, femoral neck fracture, intertrochanteric fracture, subtrochanteric fracture), surgery performed, duration of surgery, complications developed during the procedure or during postoperative follow-ups until discharge, Visual Analog Scale (VAS) at the first, second, fourth, eighth, sixteenth and twenty-fourth hours postoperatively will be recorded. During the VAS evaluation, the patient will be asked to show the location of their pain when evaluated as 0: no pain, 100: maximum pain on a 100 cm scale, and the value shown by the patient will be recorded.
During this process, additional analgesia treatment applied, if any, side effects such as headache, nausea-vomiting, hypotension, bradycardia, itching, sweating, respiratory depression due to analgesia treatment, and patient satisfaction will be recorded.
The malnutrition risk of the patients will be determined and the preoperative Nutritional Risk Score-2002 (NRS-2002), Albumin level, Prognostic Nutritional Index (PNI), GNRI, MNA-SF, Charlson Comorbidity Index (CCI) and the length of hospital stay of the patients will be recorded.
- Conditions
- Nutrition, Postoperative Pain, Hip Fracture, Geriatric
- Being tested
- Geriatric Nutrition Risk Index, visual analog scale
- Keywords
- nutritional status, hip surgery., geriatric patients, postoperative pain, postoperative prognosis
- Medical subject headings
- Pain, Postoperative, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Nutrition Risk IndexOther
Also called GNRI
GNRI will be calculated from the formula [1.489 X albumin (g/L)] + [41.7 (weight/ideal weight)]. If the patient's weight is more than their ideal weight, the weight/ideal weight ratio will be accepted as 1. The ideal weight will be calculated for men with the formula [(Height-100) -(Height-150/4)], for women with the formula [(Height-100) -(Height-150/2.5)]. According to the results, patients will be determined as no risk (GNRI > 98), low risk (92-98), severe/moderate risk (GNRI < 92).
visual analog scaleOther
Also called VAS
During the VAS evaluation, the patient will be asked to indicate the location of the pain on a 100 cm long scale where 0: no pain, 100: maximum pain, and the value shown by the patient will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric patients with hip fracture | Patients who are over the age of 65 and who will undergo surgery due to hip fracture and who agree to participate in this observational study and sign the informed consent form will be prospectively recorded using the patient follow-up forms we have prepared. Receives: Other: Geriatric Nutrition Risk Index; Other: visual analog scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between preoperative nutritional status with postoperative pain
The primary outcome variable of the study was to evaluate the correlation between preoperative nutritional status with postoperative pain, in geriatric patients undergoing hip surgery due to hip fracture.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Jan 2025
- Primary completion30 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Baldemir, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784089
- Sponsor's protocol ID
- 2024-BÇEK/193
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Fracture Type and Preoperative Nutritional Status With Postoperative Pain and Prognosis in Geriatric Hip Surgery
- ClinicalTrials.gov ID
- NCT06784089
- Acronym / sponsor ID
- 2024-BÇEK/193
- Conditions
- Nutrition, Postoperative Pain, Hip Fracture, Geriatric
- Keywords
- nutritional status, hip surgery., geriatric patients, postoperative pain, postoperative prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose/Hypothesis:
H0: There is no relationship between fracture type and preoperative nutritional status and postoperative pain and prognosis in geriatric hip surgery.
H1: There is a relationship between fracture type and preoperative nutritional status and postoperative pain and prognosis in geriatric hip surgery.
Material-Method:
This study will be conducted in accordance with the Declaration of Helsinki and will be conducted at the SBÜ Ankara Atatürk Sanatoryum Education and Research Hospital after receiving approval from the relevant units and ethics committee. The study was designed as a single-center prospective observational study.
Patients who are over the age of 65 and who will undergo surgery due to hip fracture and who agree to participate in this observational study and sign the informed consent form will be prospectively recorded using the patient follow-up forms investigators have prepared.
The standard anesthesia and analgesia protocol that investigators routinely apply to patients will be applied throughout the surgery. If the patient has pain after the surgery, the patient will not wait and the necessary analgesic treatment will be given to the patient. The patients' preoperative routine blood tests, age, height, body weight, BMI, gender, diagnoses, American Society of Anesthesiologists (ASA) physical status score, Charlson Comorbidity Index (CCI), fracture type (femoral head fracture, femoral neck fracture, intertrochanteric fracture, subtrochanteric fracture), surgery performed, duration of surgery, complications developed during the procedure or during postoperative follow-ups until discharge, Visual Analog Scale (VAS) at the first, second, fourth, eighth, sixteenth and twenty-fourth hours postoperatively will be recorded. During the VAS evaluation, the patient will be asked to show the location of their pain when evaluated as 0: no pain, 100: maximum pain on a 100 cm scale, and the value shown by the patient will be recorded.
During this process, additional analgesia treatment applied, if any, side effects such as headache, nausea-vomiting, hypotension, bradycardia, itching, sweating, respiratory depression due to analgesia treatment, and patient satisfaction will be recorded.
The malnutrition risk of the patients will be determined and the preoperative Nutritional Risk Score-2002 (NRS-2002), Albumin level, Prognostic Nutritional Index (PNI), GNRI, MNA-SF, Charlson Comorbidity Index (CCI) and the length of hospital stay of the patients will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric patients with hip fracture | – | Other: Geriatric Nutrition Risk Index, Other: visual analog scalePatients who are over the age of 65 and who will undergo surgery due to hip fracture and who agree to participate in this observational study and sign the informed consent form will be prospectively recorded using the patient follow-up forms we have prepared. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who are over the age of 65 and who will undergo surgery due to hip fracture
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Nutrition Risk IndexAlso: GNRIGNRI will be calculated from the formula [1.489 X albumin (g/L)] + [41.7 (weight/ideal weight)]. If the patient's weight is more than their ideal weight, the weight/ideal weight ratio will be accepted as 1. The ideal weight will be calculated for men with the formula [(Height-100) -(Height-150/4)], for women with the formula [(Height-100) -(Height-150/2.5)]. According to the results, patients will be determined as no risk (GNRI > 98), low risk (92-98), severe/moderate risk (GNRI < 92). | Other | Geriatric patients with hip fracture |
| visual analog scaleAlso: VASDuring the VAS evaluation, the patient will be asked to indicate the location of the pain on a 100 cm long scale where 0: no pain, 100: maximum pain, and the value shown by the patient will be recorded. | Other | Geriatric patients with hip fracture |
Primary outcome
Relationship between preoperative nutritional status with postoperative pain
Time frame: 24 hours
The primary outcome variable of the study was to evaluate the correlation between preoperative nutritional status with postoperative pain, in geriatric patients undergoing hip surgery due to hip fracture.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition and Postoperative Pain, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between preoperative nutritional status with postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.