Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Analgesia Methods and Early Mobilization in Geriatric ICU Patients After Major Surgery

15. juli 2026 opdateret af: Beyzanur Aydoğdu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Effect of Analgesia Methods on Early Mobilization and Patient Satisfaction in Geriatric Patients Admitted to Intensive Care After Major Surgery

This study looks at how different pain-control methods affect how quickly older adults get out of bed and start moving again after major surgery. Researchers will observe patients aged 65 and older who are admitted to the intensive care unit (ICU) after major surgery. Doctors will use their usual pain-control methods - either medication given through a vein, an epidural, or a nerve block - based on standard clinical practice; the study team will not change or choose the treatment. The study will record how long it takes for each patient to first sit up, stand, or walk after surgery, along with pain levels, confusion (delirium), how satisfied patients are with their pain control, and how long they stay in the ICU. The goal is to better understand which pain-control approaches may help older patients recover and move more quickly and safely after major surgery.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Early mobilization is a key component of enhanced postoperative recovery in older adults and has been associated with reduced functional decline, shorter intensive care unit (ICU) and hospital stays, and fewer postoperative complications. However, postoperative pain remains one of the main barriers to early mobilization. Although several analgesic strategies are routinely used after major surgery, their comparative effects on functional recovery in critically ill geriatric patients have not been well established in real-world clinical practice.

This is a prospective, single-center observational cohort study designed to evaluate the association between routinely administered postoperative analgesic techniques and early postoperative recovery in geriatric surgical patients requiring ICU admission. Because the study is observational, all perioperative and postoperative management, including the choice of analgesic technique, will be determined exclusively by the treating clinicians according to institutional practice. No treatment allocation, randomization, or protocol-driven intervention will be performed.

Clinical and perioperative data will be collected prospectively from routine medical records, anesthesia documentation, ICU electronic records, and nursing charts using standardized case report forms. Data quality will be ensured through predefined data collection procedures and verification before database entry. The study does not require any additional diagnostic tests, invasive procedures, blood sampling, or alterations to routine patient care.

The findings are expected to provide real-world evidence regarding the relationship between commonly used postoperative analgesic strategies and recovery after major surgery in older adults. These results may help optimize perioperative pain management protocols and support future comparative and interventional studies aimed at improving functional recovery in the geriatric surgical population.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

90

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34384
        • Rekruttering
        • University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients aged 65 years and older admitted to the intensive care unit after major surgery at a single tertiary care center, receiving one of three standard-of-care postoperative analgesia approaches (systemic, epidural, or peripheral nerve block) as determined by the treating clinical team.

Beskrivelse

Inclusion Criteria:

  • Age 65 years or older
  • ASA physical status classification I-IV
  • Admitted to the intensive care unit (ICU) following major surgery
  • ICU stay of at least 24 hours

Exclusion Criteria:

  • Previously diagnosed advanced-stage dementia
  • Inability to assess consciousness due to severe neurological deficit
  • ICU stay of less than 24 hours
  • Incomplete or insufficient clinical data

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Systemic Analgesia
Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
Medicin: Systemic Opioid Analgesia (± Multimodal)
Standard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
Epidural Analgesia
Patients who receive epidural analgesia as determined by the treating clinical team.
Procedure: Epidural Analgesia
Standard-of-care epidural analgesia administered per routine clinical practice.
Peripheral Nerve Block
Patients who receive peripheral nerve block analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
Procedure: Peripheral Nerve Block (± Multimodal)
Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Mobilization
Tidsramme: From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
Time (in hours) from ICU admission to the first time the patient achieves at least one level of mobilization - sitting at the bedside, standing, or walking - based on the ICU Mobility Scale.
From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Score
Tidsramme: At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
Pain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
Incidence of Delirium
Tidsramme: Assessed at least once daily for the first 3 days of ICU stay
Presence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.
Assessed at least once daily for the first 3 days of ICU stay
Length of ICU Stay
Tidsramme: From ICU admission to ICU discharge, up to approximately 30 days
Total number of days the patient remains in the intensive care unit.
From ICU admission to ICU discharge, up to approximately 30 days
Total Opioid Consumption
Tidsramme: From ICU admission to ICU discharge, up to approximately 30 days
Cumulative opioid dose administered, expressed as morphine milligram equivalents (mg).
From ICU admission to ICU discharge, up to approximately 30 days
Patient Satisfaction with Analgesia
Tidsramme: Assessed once, prior to ICU discharge
Patient-reported satisfaction with pain management assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Assessed once, prior to ICU discharge
Incidence and Type of Postoperative Complications
Tidsramme: From ICU admission to ICU discharge, up to approximately 30 days
Presence and type of any postoperative complications recorded during ICU stay.
From ICU admission to ICU discharge, up to approximately 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juni 2026

Primær færdiggørelse (Anslået)

15. september 2026

Studieafslutning (Anslået)

15. september 2026

Datoer for studieregistrering

Først indsendt

11. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CT-ERHO-AR-BA-04
  • E-48670771-514.99-316163880 (Anden identifikator: University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner