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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Diagnostic test: CAM ICU test; Diagnostic test: MOCA test; Diagnostic test: brief pain test; Diagnostic test: VAS scale

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 Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: bulut polat; Phone Number: +905058228095; Email: bulut.plt@gmail.com
• Study Contact Backup: Name: sinem sari öztürk; Phone Number: +905075396313; Email: sarisinem@yahoo.com

Study Locations

• Turkey
  • Efeler
    • Aydın, Efeler, Turkey, 09100
      • Recruiting
      • Adnan Menderes University
      • Contact: bulut polat; Phone Number: +905058228095; Email: bulut.plt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP BLOCK; erector spina plane block applied	Diagnostic test: CAM ICU test; CAM ICU for delirium; Diagnostic test: MOCA test; MOCA for cognitif disfonction; Diagnostic test: brief pain test; BRİEF PAİN for chronic pain; Diagnostic test: VAS scale; VAS scale for acute pain
Active Comparator: no ESP BLOCK; those who did not apply erector spina plan block	Diagnostic test: CAM ICU test; CAM ICU for delirium; Diagnostic test: MOCA test; MOCA for cognitif disfonction; Diagnostic test: brief pain test; BRİEF PAİN for chronic pain; Diagnostic test: VAS scale; VAS scale for acute pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative chronic pain assessment.we will use brief pain scoring	brief pain scoring is the test used to measure chronic pain	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	3 month later (one time)

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Director: Sinem Sari öztürk, Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2021/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No