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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04654962
• Other study ID #: CEIS-2020-083
• Status: Active, not recruiting
• Start date: October 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: December 2020
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: February 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Fractures, Bone
• Fragility Fracture
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
Colombia	Hospital Universitario Fundación Santa fe de Bogotá	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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