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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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/Surgery

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

  • Peripheral Nerve Block (± Multimodal)

    Procedure/Surgery

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Systemic Analgesia1 intervention
Group B: Epidural Analgesia1 intervention
Group C: Peripheral Nerve Block1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.

Secondary outcomes

1

Postoperative Pain Score

Pain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).

Time frame
At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
2

Incidence of Delirium

Presence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.

Time frame
Assessed at least once daily for the first 3 days of ICU stay
3

Length of ICU Stay

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

Time frame
From ICU admission to ICU discharge, up to approximately 30 days
4

Total Opioid Consumption

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

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

Other outcomes

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