Study Stopped
inactivity and unable to complete due to manpower issues
A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients
Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is compare the rates of post-operative delirium between a group of people receiving intravenous (IV) pain control after hip fracture surgery and a group of people receiving a femoral nerve catheter for pain control. Post-operative delirium is confusion that can happen after the deep sleep of anesthesia. AThe hypothesis is that the group receiving the femoral nerve catheter for pain may have a lower incidence of delirium than the group receiveing IV pain medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2012
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
February 27, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2022
CompletedApril 27, 2022
April 1, 2022
10.1 years
February 27, 2012
April 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of participants developing delirium post-operatively
3 days post-operatively
Secondary Outcomes (2)
the number of days admitted to the hospital post-operatively
participants will be followed for the duration of the hospital stay, an expected average of 4 days
Is there a difference in pain scores between subjects receiving the femoral nerve catheter vs. opioid only therapy for hip fracture pain using the visual analog scale (VAS) and consumption of pain medication for breakthrough pain relief?
post-op day 2 and again on post-op day 3
Study Arms (2)
Intravenous Opioids
ACTIVE COMPARATORFemoral Nerve Catheterization
EXPERIMENTALInterventions
A femoral nerve catheter will be placed prior to surgery in this group.
Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
Eligibility Criteria
You may qualify if:
- Age 50 and older
- Presenting to Ochsner Main Campus with a hip fracture
You may not qualify if:
- Head trauma as reported in the medical record and/or patient response
- High impact fractures as reported in the medical record
- Aphasia as reported in the medical record and/or patient response
- Deafness, blindness as reported in the medical record and/or patient response
- True allergy (not sensitivity or side effects) to local anesthetics or opiates
- Pregnant
- Inability to complete study activities pre-operatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leslie Thomaslead
- American Society of Anesthesiologistscollaborator
Study Sites (1)
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie Thomas, MD
Ochsner Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 7, 2012
Study Start
March 1, 2012
Primary Completion
April 19, 2022
Study Completion
April 19, 2022
Last Updated
April 27, 2022
Record last verified: 2022-04