Postoperative PainNCT07709975
Analgesia Methods and Early Mobilization in Geriatric ICU Patients After Major Surgery
An observational study of Postoperative Pain and Delirium - Postoperative, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Pain, Delirium - Postoperative, Frailty
- What is being tested?
- Systemic Opioid Analgesia (± Multimodal), Epidural Analgesia and Peripheral Nerve Block (± Multimodal)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul, Istanbul, 34384
Zekeriya Ervatan, MD, +90505 598 32 48, zek.ervatan@gmail.com
Beyzanur Aydoğdu, MD, +90531 367 70 76, beyzaaydogan7714@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Postoperative Pain, Delirium - Postoperative, Frailty, Postoperative Care in Geriatric Intensive Care Patients
- Being tested
- Systemic Opioid Analgesia (± Multimodal), Epidural Analgesia, Peripheral Nerve Block (± Multimodal)
- Keywords
- Geriatric, Intensive Care Unit, Major Surgery, Postoperative Analgesia, Early Mobilization, Epidural Analgesia, Peripheral Nerve Block, Opioid Consumption, Delirium, CAM-ICU, Patient Satisfaction, Frailty
- Medical subject headings
- Pain, Postoperative, Emergence Delirium, Frailty, Delirium, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AnalgesiaProcedure or surgery
Standard-of-care epidural analgesia administered per routine clinical practice.
Peripheral Nerve Block (± Multimodal)Procedure or surgery
Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Analgesia | Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team. Receives: Drug: Systemic Opioid Analgesia (± Multimodal) | |
| Epidural Analgesia | Patients who receive epidural analgesia as determined by the treating clinical team. Receives: 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. Receives: Procedure: Peripheral Nerve Block (± Multimodal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
Secondary outcomes (6)
Postoperative Pain Score
Pain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
Measured: At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
Incidence of Delirium
Presence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.
Measured: 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.
Measured: From ICU admission to ICU discharge, up to approximately 30 days
Total Opioid Consumption
Cumulative opioid dose administered, expressed as morphine milligram equivalents (mg).
Measured: 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).
Measured: Assessed once, prior to ICU discharge
Incidence and Type of Postoperative Complications
Presence and type of any postoperative complications recorded during ICU stay.
Measured: From ICU admission to ICU discharge, up to approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Jun 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyzanur Aydoğdu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709975
- Sponsor's protocol ID
- CT-ERHO-AR-BA-04
- Other IDs
- E-48670771-514.99-316163880
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Analgesia Methods on Early Mobilization and Patient Satisfaction in Geriatric Patients Admitted to Intensive Care After Major Surgery
- ClinicalTrials.gov ID
- NCT07709975
- Acronym / sponsor ID
- CT-ERHO-AR-BA-04
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic Analgesia | – | Drug: Systemic Opioid Analgesia (± Multimodal)Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team. |
| Epidural Analgesia | – | Procedure: Epidural AnalgesiaPatients who receive epidural analgesia as determined by the treating clinical team. |
| Peripheral Nerve Block | – | Procedure: Peripheral Nerve Block (± Multimodal)Patients who receive peripheral nerve block analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic Opioid Analgesia (± Multimodal)Standard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice. | Drug | Systemic Analgesia |
| Epidural AnalgesiaStandard-of-care epidural analgesia administered per routine clinical practice. | Procedure or surgery | Epidural Analgesia |
| Peripheral Nerve Block (± Multimodal)Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice. | Procedure or surgery | Peripheral Nerve Block |
Primary outcome
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.
6 secondary outcomes
Postoperative Pain Score
Time frame: 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
Length of ICU Stay
Time frame: 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
Patient Satisfaction with Analgesia
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Delirium - Postoperative, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zekeriya Ervatan, MD (+90505 598 32 48, zek.ervatan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Mobilization (time frame: From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.