Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery
Primary Purpose
Postoperative Delirium
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CAM ICU test
MOCA test
brief pain test
VAS scale
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Delirium
Eligibility Criteria
Inclusion Criteria:
- 60 and older
- ASA Physical Status 1-3;
- Scheduled for elective hip surgery under spinal anesthesia
- MMSE ≥ 20 (to exclude dementia)
Exclusion Criteria:
- Severe visual or auditory disorder/handicaps
- Bipolar disorder
- major depression
- schizophrenia
- Alzheimer
- Dementia
- ASA physical status IV or V
Sites / Locations
- Adnan Menderes UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ESP BLOCK
no ESP BLOCK
Arm Description
erector spina plane block applied
those who did not apply erector spina plan block
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
postoperative chronic pain assessment.we will use brief pain scoring
brief pain scoring is the test used to measure chronic pain
postoperative cognitive dysfunction assessment.we will use montreal cognitive assesment test
montreal cognitive assesment is the test used to measure postoperative cognitive dysfunction
Full Information
NCT ID
NCT05276648
First Posted
January 31, 2022
Last Updated
March 2, 2022
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT05276648
Brief Title
Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery
Official Title
Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESP BLOCK
Arm Type
Experimental
Arm Description
erector spina plane block applied
Arm Title
no ESP BLOCK
Arm Type
Active Comparator
Arm Description
those who did not apply erector spina plan block
Intervention Type
Diagnostic Test
Intervention Name(s)
CAM ICU test
Intervention Description
CAM ICU for delirium
Intervention Type
Diagnostic Test
Intervention Name(s)
MOCA test
Intervention Description
MOCA for cognitif disfonction
Intervention Type
Diagnostic Test
Intervention Name(s)
brief pain test
Intervention Description
BRİEF PAİN for chronic pain
Intervention Type
Diagnostic Test
Intervention Name(s)
VAS scale
Intervention Description
VAS scale for acute pain
Primary Outcome Measure Information:
Title
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.
Description
CAM ICU IS THE TEST USED TO MEASURE DELIRIUM
Time Frame
Change from baseline postoperative delirium at five days
Secondary Outcome Measure Information:
Title
postoperative chronic pain assessment.we will use brief pain scoring
Description
brief pain scoring is the test used to measure chronic pain
Time Frame
3 month later (one time)
Title
postoperative cognitive dysfunction assessment.we will use montreal cognitive assesment test
Description
montreal cognitive assesment is the test used to measure postoperative cognitive dysfunction
Time Frame
3 month later (one time)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
60 and older
ASA Physical Status 1-3;
Scheduled for elective hip surgery under spinal anesthesia
MMSE ≥ 20 (to exclude dementia)
Exclusion Criteria:
Severe visual or auditory disorder/handicaps
Bipolar disorder
major depression
schizophrenia
Alzheimer
Dementia
ASA physical status IV or V
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BULUT POLAT
Phone
+905058228095
Email
bulut.plt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
sinem sari öztürk
Phone
+905075396313
Email
sarisinem@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinem Sari öztürk
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Study Director
Facility Information:
Facility Name
Adnan Menderes University
City
Aydın
State/Province
Efeler
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bulut polat
Phone
+905058228095
Email
bulut.plt@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery
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