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

15 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

90

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Istanbul
      • Istanbul, Istanbul, Turquia (Türkiye), 34384
        • Recrutamento
        • University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Systemic Analgesia
Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
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.
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.
Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time to First Mobilization
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Postoperative Pain Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de junho de 2026

Conclusão Primária (Estimado)

15 de setembro de 2026

Conclusão do estudo (Estimado)

15 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

11 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de julho de 2026

Primeira postagem (Real)

17 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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