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| ID | Type | Description | Link |
|---|---|---|---|
| E-48670771-514.99-316163880 | Other Identifier | University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic Analgesia | Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team. |
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| Epidural Analgesia | Patients who receive epidural analgesia as determined by the treating clinical team. |
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| Peripheral Nerve Block | Patients who receive peripheral nerve block analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zekeriya Ervatan, MD | Contact | +90505 598 32 48 | zek.ervatan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital | Recruiting | Istanbul | Istanbul | 34384 | Turkey (Türkiye) |
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| Epidural Analgesia | Procedure | Standard-of-care epidural analgesia administered per routine clinical practice. |
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| 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. |
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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 | 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 | 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 | 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 | Presence and type of any postoperative complications recorded during ICU stay. | From ICU admission to ICU discharge, up to approximately 30 days |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000071257 | Emergence Delirium |
| D000073496 | Frailty |
| D003693 | Delirium |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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