Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the HUFSFB and HUSJI From 2019 - 2020

Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the Fundacion Santa fe de Bogotá University Hospital and Infantil San Jose University Hospital From 2019 - 2020

The purpose of this study is to identify the association between analgesic management with blockade of the iliac fascia versus intravenous analgesia with the presence of delirium during hospital stay in patients admitted to the orthogeriatric clinical care center, to determine the opioid consumption of both groups of patients during hospitalization and determine the risk factors that may be associated with a greater presentation of delirium.

Study Overview

• Status: Unknown
• Conditions: Hip Fractures; Delirium in Old Age; Fragility Fracture
• Intervention / Treatment: Procedure: Anesthetic nerve block

Detailed Description

Nowadays, with the increase in the geriatric population, there is evidence of an increase in the prevalent conditions in this group, finding within them fragility hip fractures. Additionally, most of these patients have a large number of associated comorbidities, which may require greater specialization in care.

To reduce the possible complications that may be related, different management protocols have been implemented, including pain management strategies such as preventive analgesics, regional blocks, and early surgery. Conventional treatment with the use of intravenous medications can have unwanted effects in geriatric patients with hip fracture, especially in those with greater comorbidity, since medications such as opioids can cause multiple adverse effects, including delirium. Also, not treating pain properly can cause complications such as depression and ulcers in addition to delirium.

This is why the objective of this study is to define whether there is any association between the presentation of delirium in patients over 65 years of age with hip fracture who undergo iliac fascia block upon admission compared to those who receive only IV analgesia Therefore, this retrospective cohort study will be carried out with which it is sought to contribute to the knowledge to continue carrying out early pain management, with the aim of achieving better pain control, a decrease in opioid consumption and thus having a lower number of patients with delirium during hospitalization.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • Hospital Universitario Fundación Santa Fé de Bogota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Patients older than 65 years with a diagnosis of hip fracture who are admitted to the Orthogeriatric Clinical Care Center at the Santa Fe de Bogotá Foundation in a period between January 2019 and December 2020.
• Patients over 65 years of age with a diagnosis of hip fracture who enter the Excellence Program in Orthogeriatrics at the San José Infantil University Hospital in a period between January 2019 and December 2020.

Description

Inclusion Criteria:

• Patients over 65 years of age with a diagnosis of hip fracture due to fragility who are admitted to the Orthogeriatric clinical care center at the Santa Fe de Bogotá Foundation and the San José Infantil University Hospital between January 2019 and December 2020. These two institutions are selected Since they have a model of care for this type of patient, it is similar and therefore comparable.

Exclusion Criteria:

• Patients diagnosed with delirium on admission to the emergency room.
• Patients with hip fracture caused by high energy trauma
• Patients with hip fracture related with tumoral disease or metastasis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients receiving preoperative analgesic management with anesthetic block; This cohort includes all patients that received preoperative anesthetic block for hip fracture surgery as main analgesic management during the study period.	Procedure: Anesthetic nerve block; iliac fascia block is an analgesic technique that uses local anesthesia, is effective and relatively safe in preoperative management. The target of this block is the femoral and lateral femoral cutaneous nerves; which innervate the anterior aspect of the thigh, as well as the muscle and periosteum that covers the femoral head, neck and proximal femur.
patients receiving conventional preoperative analgesic management; This cohort includes all patients that received conventional preoperative analgesic management (oral, intravenous or intramuscular medication) for hip fracture surgery as main analgesic management during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In hospital Delirium	Presence of delirium measured with the Confusion Assessment Method (CAM) scale during hospitalization. The CAM scale assesses the presence and severity of delirium, and its algorithm is based on four main features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Fundación Santa Fe de Bogota
• Investigators: Principal Investigator: Carlos M Olarte, MD, Orthopedic Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): January 15, 2021
• Study Completion (Anticipated): February 15, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CEIS-2020-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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