ClinicalTrials.gg
RecruitingNCT07709975Updated Jul 17, 2026

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

An observational study in Postoperative Pain, Delirium - Postoperative and Frailty, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
65 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 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
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 90 is below the median of 102 across 683 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 87 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 65 years or older
  • classification I-IV
  • Admitted to the intensive care unit (ICU) following major surgery
  • ICU stay of at least 24 hours

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugSystemic Opioid Analgesia (± Multimodal)

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

  • ProcedureEpidural Analgesia

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

  • ProcedurePeripheral Nerve Block (± Multimodal)

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

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What researchers measure

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

  5. Patient Satisfaction with Analgesia

    Patient-reported satisfaction with pain management assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).

    Time frame: Assessed once, prior to ICU discharge

  6. Incidence and Type of Postoperative Complications

    Presence and type of any postoperative complications recorded during ICU stay.

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

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Study locations

1 of 1 sites recruiting
  • University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
    Istanbul, Istanbul 34384, Turkey (Türkiye)
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Sep 2026, 3 months after the start.

Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 3 months is below that.

Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2026
First posted
Jul 17, 2026
StartActual
Jun 15, 2026
Primary completionEst.
Sep 15, 2026
CompletionEst.
Sep 15, 2026
Last update
Jul 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07709975
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible party
Beyzanur Aydoğdu (Specialist Physician, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization) — Principal investigator
First posted
Jul 17, 2026
Start date
Jun 15, 2026
Primary completion
Sep 15, 2026 (estimated)
Completion
Sep 15, 2026 (estimated)
Last update
Jul 17, 2026

Study contacts

Zekeriya Ervatan, MD
Contact
zek.ervatan@gmail.com
+90505 598 32 48

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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