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UndernutritionNCT06802575

The Postsurgical Pain in Elderly Patients Suffering From Undernourishment

An observational study of Undernutrition and Pain, run by Democritus University of Thrace at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

INTRODUCTION Undernourishment is the situation when someone does not consume all the essential nutrients for the metabolic functions of the body. It is crystal clear for clinicians that undernourishment is considered as a factor of poor clinical outcome; however, it is being underestimated. Read more about this study

Who is it for?
Ages 70 to 100 years
Conditions the study is for
Undernutrition, Pain
How many people
81 participants
Where
1 siteGreece
Study dates
1 Apr 2020to 31 Dec 2024
How long will I take part?
6 Months
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 70 to 100 years
  • All sexes
  • Older adult

Study population: Surgical patients, with nutritonal deficits or not, at least 70 years old, after sigbing consent form

Who may be able to join

  • Age ≥70 years old
  • consent form for the participation
  • scheduled or emergent surgeries or revision of them.

Who cannot join

  • Patients with psychiatric background
  • cancer patients
  • corticosteroid therapy or chemotherapy
  • patients with chronic inflammatory diseases of the gastrointestinal system.

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • General Hospital of Drama

    Drama

Other trials in Greece

About this study

Official title: Nutritional Screening and Inflammation: Key Biomarkers of Postoperative Pain and Recovery in Elderly Surgical Patients

INTRODUCTION Undernourishment is the situation when someone does not consume all the essential nutrients for the metabolic functions of the body. It is crystal clear for clinicians that undernourishment is considered as a factor of poor clinical outcome; however, it is being underestimated. The prevalence of it is not the same globally because of the lack of diagnostic criteria. There have been some researchers who have suggested different prognostic and diagnostic scores and laboratory exercises and most of them are now considered reliable. With the rapid growth of elderly population, much more patients of this age group are hospitalized for scheduled or emergent operations. A big percentage suffers from nutritional deficiencies, while an operation is considered as a hypermetabolic period. This worsens the postoperative period even more because of the co-morbidities and prolongs the hospitalization, raises the number of complications and the in-hospital mortality and the health care cost. Pain is one more factor which entangles the postoperative and rehabilitation period, so acute and chronic pain should not been forgotten. There are no data available which relate the acute and chronic postoperative pain with undernourishment, while it would be interesting for us to find out if the treatment of surgical pain in the undernourished patients is efficient.

AIM In this non-interventional observational prospective study, the investigators examine the level of postoperative pain, acute or chronic, in undernourished elderly patients and also the incidence of postoperative complications and the possible hospital readmission within 30 days period from the surgical procedure in comparison with the patients with no nutritional deficiencies. The study findings will help us to provide better intraoperative management of undernourished patients in order to achieve a more advantageous postoperative result.

METHODS In this study, surgical patients with age ≥70 years old will be separated in 2 groups, after the categorization of them in undernourished or not. The investigators will include patients aged ≥70 years old that they are admitted in the hospital and will receive anesthesia either for scheduled or for emergent surgical procedure. Preoperatively, some scores and laboratory exercises will be conducted which are considered the most accepted tools for the diagnosis of undernourishment. VAS (Visual Analog Scale), MNA (Mini Nutritional Assessment tool) and NUTRIC (Nutrition Risk in the Critically Ill) scores, with the last one being the most accepted one from both the Society of Critical Care Medicine (SCCM) and American Society for Parental and Enteral Nutrition (A.S.P.E.N.) will be conducted as diagnostic tools. The investigators will assess the following preoperative laboratory exercises: Exercises for Kidney and Liver function, Electrolytes, Biomarkers of Inflammation and Adipokines. Furthermore, all patients under general anesthesia will be monitored with NOL (Nociception Level Index) monitor. Group A will be consisted of undernourished patients for scheduled or emergent surgery and Group B will be consisted of patients with normal nutritional status. First of all, the acute postoperative pain, according to VAS score, right after surgery, 24 hours postoperative and 3-7 days after (the first 7 postoperative days are considered as a hypermetabolic period) will be compared between the 2 Groups and secondly, the chronic postoperative day, according to VAS score too, 30 days after surgery and after 6 months. Moreover, the investigators will study the relationship between undernourishment and demographic factors (gender, age and smoking), functional capability in day life, morbidity according to ASA score, surgical data, postoperative complications, readmission within 30 days after discharge and mortality within the same period of time. Inclusion criteria will be the following: Age ≥70 years old, consent form for the participation, scheduled or emergent surgeries or revision of them. Exclusion criteria will be the following: Patients with psychiatric background, cancer patients, corticosteroid therapy or chemotherapy and patients with chronic inflammatory diseases of the gastrointestinal system.

Conditions
Undernutrition, Pain
Medical subject headings
Malnutrition, Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of nutritional status and postsurgical pain

    The primary outcome of this study is to evaluate whether nutritional deficiencies, as identified by these scores, are associated with higher levels of acute and chronic postoperative pain

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start1 Apr 2020
  3. Primary completion31 Mar 2024
  4. Study completion31 Dec 2024

Resources

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
81 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06802575
Sponsor's protocol ID
ΔΠΘ/ΤΙΑΤΡ/35548/3207
Status last verified
Feb 2025
First submitted
26 Jan 2025
Last updated
4 Feb 2025
Results posted
No

Publications

  • Ioannidis R, Sarridou D, Tsigalou C, Bampoulas A, Chloropoulou P. Bridging the Gap: The Impact of Preoperative Nutritional Status and Inflammation in Postoperative Pain in Elderly Patients. Anesthesiol Res Pract. 2025 Aug 28;2025:6832202. doi: 10.1155/anrp/6832202. eCollection 2025.

    PubMed 40917986

Questions about this trial

What is this clinical trial studying?

An observational study of Undernutrition and Pain, run by Democritus University of Thrace at 1 site in Greece.

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 3 inclusion and 4 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 4 Feb 2025. 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 Greece. 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?

Correlation of nutritional status and postsurgical pain (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06802575, which also lists 1 linked publication.

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 4 Feb 2025.

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