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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07709975
Enrollment
90
Registered
2026-07-17
Start date
2026-06-15
Completion date
2026-09-15
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium - Postoperative, Frailty, Postoperative Care in Geriatric Intensive Care Patients, Postoperative Pain

Keywords

Geriatric, Intensive Care Unit, Major Surgery, Postoperative Analgesia, Early Mobilization, Epidural Analgesia, Peripheral Nerve Block, Opioid Consumption, Delirium, CAM-ICU, Patient Satisfaction, Frailty

Brief summary

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.

Detailed description

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.

Interventions

DRUGSystemic Opioid Analgesia (± Multimodal)

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

PROCEDUREEpidural Analgesia

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

PROCEDUREPeripheral Nerve Block (± Multimodal)

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

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to First MobilizationFrom 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

MeasureTime frameDescription
Postoperative Pain ScoreAt ICU admission, and at 6, 12, 24, and 48 hours after ICU admissionPain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
Incidence of DeliriumAssessed at least once daily for the first 3 days of ICU stayPresence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.
Length of ICU StayFrom ICU admission to ICU discharge, up to approximately 30 daysTotal number of days the patient remains in the intensive care unit.
Total Opioid ConsumptionFrom ICU admission to ICU discharge, up to approximately 30 daysCumulative opioid dose administered, expressed as morphine milligram equivalents (mg).
Patient Satisfaction with AnalgesiaAssessed once, prior to ICU dischargePatient-reported satisfaction with pain management assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Incidence and Type of Postoperative ComplicationsFrom ICU admission to ICU discharge, up to approximately 30 daysPresence and type of any postoperative complications recorded during ICU stay.

Countries

Turkey (Türkiye)

Contacts

CONTACTZekeriya Ervatan, MD
zek.ervatan@gmail.com+90505 598 32 48

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026