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

NCT05276648 | Unknown DMC

• 1 other identifier: 2021/05
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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

  Change from baseline postoperative delirium at five days

Secondary Outcomes (2)

• postoperative chronic pain assessment.we will use brief pain scoring

  3 month later (one time)

• postoperative cognitive dysfunction assessment.we will use montreal cognitive assesment test

  3 month later (one time)

Study Arms (2)

ESP BLOCK

EXPERIMENTAL

erector spina plane block applied

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

Diagnostic Test: CAM ICU test; Diagnostic Test: MOCA test; Diagnostic Test: brief pain test; Diagnostic Test: VAS scale

Interventions

CAM ICU test DIAGNOSTIC_TEST

CAM ICU for delirium

ESP BLOCK; no ESP BLOCK

MOCA test DIAGNOSTIC_TEST

MOCA for cognitif disfonction

ESP BLOCK; no ESP BLOCK

brief pain test DIAGNOSTIC_TEST

BRİEF PAİN for chronic pain

ESP BLOCK; no ESP BLOCK

VAS scale DIAGNOSTIC_TEST

VAS scale for acute pain

ESP BLOCK; no ESP BLOCK

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe visual or auditory disorder/handicaps
• Bipolar disorder
• major depression
• schizophrenia
• Alzheimer
• Dementia
• ASA physical status IV or V

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University

Aydin, Efeler, 09100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sinem Sari öztürk

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Central Study Contacts

BULUT POLAT

CONTACT

+905058228095; bulut.plt@gmail.com

sinem sari öztürk

CONTACT

+905075396313; sarisinem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 11, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)