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

July 15, 2026 updated by: Beyzanur Aydoğdu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34384
        • Recruiting
        • University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Standard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
Epidural Analgesia
Patients who receive epidural analgesia as determined by the treating clinical team.
Procedure: Epidural Analgesia
Standard-of-care epidural analgesia administered per routine clinical practice.
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)
Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Mobilization
Time Frame: From 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.
From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
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
Time Frame: Assessed at least once daily for the first 3 days of ICU stay
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
Time Frame: From ICU admission to ICU discharge, up to approximately 30 days
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
Time Frame: From ICU admission to ICU discharge, up to approximately 30 days
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
Time Frame: Assessed once, prior to ICU discharge
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
Time Frame: From ICU admission to ICU discharge, up to approximately 30 days
Presence and type of any postoperative complications recorded during ICU stay.
From ICU admission to ICU discharge, up to approximately 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-ERHO-AR-BA-04
  • E-48670771-514.99-316163880 (Other Identifier: University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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