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

NCT07709975 | Recruiting

• 2 other identifiers: CT-ERHO-AR-BA-04E-48670771-514.99-316163880
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (6)

• Postoperative Pain Score

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

• Incidence of Delirium

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

• Length of ICU Stay

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

• Total Opioid Consumption

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

• Patient Satisfaction with Analgesia

  Assessed once, prior to ICU discharge

Study Arms (3)

Systemic Analgesia

Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.

Drug: Systemic Opioid Analgesia (± Multimodal)

Epidural Analgesia

Patients who receive epidural analgesia as determined by the treating clinical team.

Procedure: Epidural Analgesia

Peripheral Nerve Block

Patients who receive peripheral nerve block analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.

Procedure: Peripheral Nerve Block (± Multimodal)

Interventions

Epidural Analgesia PROCEDURE

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

Epidural Analgesia

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.

Peripheral Nerve Block

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.

Systemic Analgesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Istanbul, 34384, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Emergence Delirium; Frailty; Delirium; Patient Satisfaction

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Zekeriya Ervatan, MD

CONTACT

+90505 598 32 48; zek.ervatan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)