Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery

NCT ID: NCT05276648

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-02-01

Brief Summary

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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

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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

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ESP BLOCK

erector spina plane block applied

Group Type EXPERIMENTAL

CAM ICU test

Intervention Type DIAGNOSTIC_TEST

CAM ICU for delirium

MOCA test

Intervention Type DIAGNOSTIC_TEST

MOCA for cognitif disfonction

brief pain test

Intervention Type DIAGNOSTIC_TEST

BRİEF PAİN for chronic pain

VAS scale

Intervention Type DIAGNOSTIC_TEST

VAS scale for acute pain

no ESP BLOCK

those who did not apply erector spina plan block

Group Type ACTIVE_COMPARATOR

CAM ICU test

Intervention Type DIAGNOSTIC_TEST

CAM ICU for delirium

MOCA test

Intervention Type DIAGNOSTIC_TEST

MOCA for cognitif disfonction

brief pain test

Intervention Type DIAGNOSTIC_TEST

BRİEF PAİN for chronic pain

VAS scale

Intervention Type DIAGNOSTIC_TEST

VAS scale for acute pain

Interventions

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CAM ICU test

CAM ICU for delirium

Intervention Type DIAGNOSTIC_TEST

MOCA test

MOCA for cognitif disfonction

Intervention Type DIAGNOSTIC_TEST

brief pain test

BRİEF PAİN for chronic pain

Intervention Type DIAGNOSTIC_TEST

VAS scale

VAS scale for acute pain

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 60 and older
2. ASA Physical Status 1-3;
3. Scheduled for elective hip surgery under spinal anesthesia
4. MMSE ≥ 20 (to exclude dementia)

Exclusion Criteria

1. Severe visual or auditory disorder/handicaps
2. Bipolar disorder
3. major depression
4. schizophrenia
5. Alzheimer
6. Dementia
7. ASA physical status IV or V
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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BULUT POLAT

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinem Sari öztürk

Role: STUDY_DIRECTOR

Aydin Adnan Menderes University

Locations

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Adnan Menderes University

Aydin, Efeler, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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BULUT POLAT

Role: CONTACT

+905058228095

sinem sari öztürk

Role: CONTACT

+905075396313

Facility Contacts

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bulut polat

Role: primary

+905058228095

Other Identifiers

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2021/05

Identifier Type: -

Identifier Source: org_study_id

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