Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07709975

Analgesia Methods and Early Mobilization in Geriatric ICU Patients 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Postoperative Pain Behavior Confusion Delirium Delirium - Postoperative Emergence Delirium Frailty Health Behavior Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Postoperative Care in Geriatric Intensive Care Patients Postoperative Complications Signs and Symptoms Treatment Adherence and Compliance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systemic Opioid Analgesia (± Multimodal)

Drug

Standard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.

Epidural Analgesia

Procedure

Standard-of-care epidural analgesia administered per routine clinical practice.

Peripheral Nerve Block (± Multimodal)

Procedure

Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.

Primary outcomes

  1. Time to First Mobilization

    Time frame: 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.

Secondary outcomes

  1. Postoperative Pain Score

    Time frame: 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).

  2. Incidence of Delirium

    Time frame: 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.

  3. Length of ICU Stay

    Time frame: From ICU admission to ICU discharge, up to approximately 30 days

    Total number of days the patient remains in the intensive care unit.

  4. Total Opioid Consumption

    Time frame: From ICU admission to ICU discharge, up to approximately 30 days

    Cumulative opioid dose administered, expressed as morphine milligram equivalents (mg).

  5. Patient Satisfaction with Analgesia

    Time frame: 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).

  6. Incidence and Type of Postoperative Complications

    Time frame: From ICU admission to ICU discharge, up to approximately 30 days

    Presence and type of any postoperative complications recorded during ICU stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Zekeriya Ervatan, MD

CONTACT

[email protected]

+90505 598 32 48

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.