Postoperative DeliriumNCT05276648
Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery
A study testing CAM ICU test, MOCA test and brief pain test in people with Postoperative Delirium, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar vertebra surgery is one of the most common surgical procedures.Delirium is common in geriatric patients after lumbar spinae surgery.postoperative delirium usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- CAM ICU test, MOCA test and brief pain test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 60 and older
- ASA Physical Status 1-3;
- Scheduled for elective hip surgery under spinal anesthesia
- MMSE ≥ 20 (to exclude dementia)
Who cannot join
- Severe visual or auditory disorder/handicaps
- Bipolar disorder
- major depression
- schizophrenia
- Alzheimer
- Dementia
- ASA physical status IV or V
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adnan Menderes University
Aydin, Efeler, 09100
bulut polat, +905058228095, bulut.plt@gmail.com
About this study
Lumbar vertebra surgery is one of the most common surgical procedures.Delirium is common in geriatric patients after lumbar spinae surgery.postoperative delirium usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.
The aim of this study was to investigate the effect of this field block on postoperative delirium in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.
Read the detailed description
Postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are extremely common in geriatric surgical patients. After elective major joint replacement or other types of major surgery, about 5% to 15% of elders develop delirium and 25% to 40% and 12% to 15% developearly or late POCD. PDand POCD are associated with prolonged length of stay, discharge to a place other than home and higher 1 year mortality. In addition, delirium is associated with an accelerated trajectory of cognitive decline to dementia (1). The etiologies of both PD and POCD remain unknown. Controversy exists over whether delirium is a marker or risk factor for subsequent persistent cognitive impairment . The PD is an acute impairment of cognitive and or spatial/temporal perception,that can be diagnosed at the bedside with dedicated diagnostic tools. It has an acute onset and a fluctuating course, and therefore can be missed if not systematically tested. It is defined by three principal characteristics: altered consciousness; changes in cognitive abilities; recent and rapid onset . The POCD affects global cognitive functions for several months/years after surgery and anesthesia, diagnosis requires detailed neuropsychological testing.
Surgical interventions have been associated with severe pain and discomfort in the immediate perioperative period. Surgical anesthesia and the perioperative analgesic regimen aim toward complete intra-operative amnesia, profound analgesia, effective control of autonomic responses and rapid emergence. However, anesthesia, analgesia and sedation all utilize medications that might be implicated in the development of central nervous system (CNS) dysfunction. Elderly patients are more sensitive to the CNS effects of barbiturates, inhalationalanesthetics, benzodiazepines and opioids. Some medications frequently associated with delirium with or without POCD include opioids, anxiolytics, antidepressants, and corticosteroids.
There are studies regarding the effect of erektor spina field block on postoperative pain in vertebra surgery.The investigators will compare the effect on postoperative delirium of patients who underwent erector spina plane block after spinal surgery with those who did not.
- Conditions
- Postoperative Delirium
- Being tested
- CAM ICU test, MOCA test, brief pain test, VAS scale
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM ICU testDiagnostic test
CAM ICU for delirium
MOCA testDiagnostic test
MOCA for cognitif disfonction
brief pain testDiagnostic test
BRİEF PAİN for chronic pain
VAS scaleDiagnostic test
VAS scale for acute pain
| Study group | Role | What they receive |
|---|---|---|
| ESP BLOCK | Experimental | erector spina plane block applied Receives: Diagnostic Test: CAM ICU test; Diagnostic Test: MOCA test; Diagnostic Test: brief pain test; Diagnostic Test: VAS scale |
| no ESP BLOCK | Active comparator | those who did not apply erector spina plan block Receives: Diagnostic Test: CAM ICU test; Diagnostic Test: MOCA test; Diagnostic Test: brief pain test; Diagnostic Test: VAS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effect of postoperative delirium (determined by CAM ICU test) in patients who underwent erector spina block after spinal surgery and those who did not.
CAM ICU IS THE TEST USED TO MEASURE DELIRIUM
Measured: Change from baseline postoperative delirium at five days
Secondary outcomes (2)
postoperative chronic pain assessment.we will use brief pain scoring
brief pain scoring is the test used to measure chronic pain
Measured: 3 month later (one time)
postoperative cognitive dysfunction assessment.we will use montreal cognitive assesment test
montreal cognitive assesment is the test used to measure postoperative cognitive dysfunction
Measured: 3 month later (one time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Feb 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BULUT POLAT, Aydin Adnan Menderes University
- Investigators
- Sinem Sari öztürk, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276648
- Sponsor's protocol ID
- 2021/05
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT05276648
- Acronym / sponsor ID
- 2021/05
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 11 Mar 2022 (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.
Lumbar vertebra surgery is one of the most common surgical procedures.Delirium is common in geriatric patients after lumbar spinae surgery.postoperative delirium usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.
The aim of this study was to investigate the effect of this field block on postoperative delirium in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.
Detailed description
Postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are extremely common in geriatric surgical patients. After elective major joint replacement or other types of major surgery, about 5% to 15% of elders develop delirium and 25% to 40% and 12% to 15% developearly or late POCD. PDand POCD are associated with prolonged length of stay, discharge to a place other than home and higher 1 year mortality. In addition, delirium is associated with an accelerated trajectory of cognitive decline to dementia (1). The etiologies of both PD and POCD remain unknown. Controversy exists over whether delirium is a marker or risk factor for subsequent persistent cognitive impairment . The PD is an acute impairment of cognitive and or spatial/temporal perception,that can be diagnosed at the bedside with dedicated diagnostic tools. It has an acute onset and a fluctuating course, and therefore can be missed if not systematically tested. It is defined by three principal characteristics: altered consciousness; changes in cognitive abilities; recent and rapid onset . The POCD affects global cognitive functions for several months/years after surgery and anesthesia, diagnosis requires detailed neuropsychological testing.
Surgical interventions have been associated with severe pain and discomfort in the immediate perioperative period. Surgical anesthesia and the perioperative analgesic regimen aim toward complete intra-operative amnesia, profound analgesia, effective control of autonomic responses and rapid emergence. However, anesthesia, analgesia and sedation all utilize medications that might be implicated in the development of central nervous system (CNS) dysfunction. Elderly patients are more sensitive to the CNS effects of barbiturates, inhalationalanesthetics, benzodiazepines and opioids. Some medications frequently associated with delirium with or without POCD include opioids, anxiolytics, antidepressants, and corticosteroids.
There are studies regarding the effect of erektor spina field block on postoperative pain in vertebra surgery.The investigators will compare the effect on postoperative delirium of patients who underwent erector spina plane block after spinal surgery with those who did not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP BLOCK | Experimental | Diagnostic Test: CAM ICU test, Diagnostic Test: MOCA test, Diagnostic Test: brief pain test, Diagnostic Test: VAS scaleerector spina plane block applied |
| no ESP BLOCK | Active comparator | Diagnostic Test: CAM ICU test, Diagnostic Test: MOCA test, Diagnostic Test: brief pain test, Diagnostic Test: VAS scalethose who did not apply erector spina plan block |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 60 and older
- ASA Physical Status 1-3;
- Scheduled for elective hip surgery under spinal anesthesia
- MMSE ≥ 20 (to exclude dementia)
Key exclusion criteria (7 listed)
- Severe visual or auditory disorder/handicaps
- Bipolar disorder
- major depression
- schizophrenia
- Alzheimer
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 |
|---|---|---|
| CAM ICU testCAM ICU for delirium | Diagnostic test | ESP BLOCK, no ESP BLOCK |
| MOCA testMOCA for cognitif disfonction | Diagnostic test | ESP BLOCK, no ESP BLOCK |
| brief pain testBRİEF PAİN for chronic pain | Diagnostic test | ESP BLOCK, no ESP BLOCK |
| VAS scaleVAS scale for acute pain | Diagnostic test | ESP BLOCK, no ESP BLOCK |
Primary outcome
Comparison of the effect of postoperative delirium (determined by CAM ICU test) in patients who underwent erector spina block after spinal surgery and those who did not.
Time frame: Change from baseline postoperative delirium at five days
CAM ICU IS THE TEST USED TO MEASURE DELIRIUM
2 secondary outcomes
postoperative chronic pain assessment.we will use brief pain scoring
Time frame: 3 month later (one time)
postoperative cognitive dysfunction assessment.we will use montreal cognitive assesment test
Time frame: 3 month later (one time)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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. This study is not recruiting at the moment.
Sinem Sari öztürk study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAM ICU test, MOCA test and brief pain test in people with Postoperative Delirium, run by Aydin Adnan Menderes University 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 7 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BULUT POLAT (+905058228095, bulut.plt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the effect of postoperative delirium (determined by CAM ICU test) in patients who underwent erector spina block after spinal surgery and those who did not. (time frame: Change from baseline postoperative delirium at five 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 11 Mar 2022.