NCT04654962

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

November 25, 2020

Last Update Submit

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.

Procedure: Anesthetic nerve block

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.

patients receiving preoperative analgesic management with anesthetic block

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Carlos M Olarte, MD

    Orthopedic surgeon

    PRINCIPAL INVESTIGATOR

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

Locations