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
1 other identifier
observational
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
December 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedDecember 4, 2020
December 1, 2020
4 months
November 25, 2020
December 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
* 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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Fundación Santa fe de Bogotá
Bogotá, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos M Olarte, MD
Orthopedic surgeon
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical research assistant of the Orthogeriatric Clinical Care Center
Study Record Dates
First Submitted
November 25, 2020
First Posted
December 4, 2020
Study Start
October 1, 2020
Primary Completion
January 15, 2021
Study Completion
February 15, 2021
Last Updated
December 4, 2020
Record last verified: 2020-12