About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Systemic Opioid Analgesia (± Multimodal)
DrugStandard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
Epidural Analgesia
Procedure/SurgeryStandard-of-care epidural analgesia administered per routine clinical practice.
Peripheral Nerve Block (± Multimodal)
Procedure/SurgeryStandard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
Treatment groups
Trial outcomes
Primary outcomes
Time to First Mobilization
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
Postoperative Pain Score
Pain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
Incidence of Delirium
Presence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.
Length of ICU Stay
Total number of days the patient remains in the intensive care unit.
Total Opioid Consumption
Cumulative opioid dose administered, expressed as morphine milligram equivalents (mg).
Sponsors and contacts
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