- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01547468
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will have their hearing and vision tested. They will have their ability to think and analyze information tested using 4 questionnaires/ surveys: The Confusion Assesment Method (CAM), the Mini-Mental Status Examination (MMSE), Modified Blessed Dementia scale (MBDS), and Barthel's Activities of Daily Living (ADL). They will have pain medication prior to surgery based on the doctor's orders.
On the day of surgery, subjects will be randomized (like a flip of a coin) into one of two groups. One group will receive IV medication to control for pain after surgery. The other group will receive a femoral nerve catheter to control for pain after surgery.
A femoral nerve catheter is the small tubing that delivers numbing medicine to the nerves around the hips that control pain. This will be placed either before, during or soon after your surgery to help with pain after the surgery. This catheter is placed using an ultrasound machine. Subjects will still have pain medication through the IV before surgery if the catheter is put into their leg.
After surgery, you will be given the pain medication either through the IV or through the catheter in your leg. The catheter will be left in after surgery for 2-3 days delivering numbing medicine to the nerves. If subjects have the catheter in their leg and need more pain medication, the medication will be given to them through the IV.
Subjects will be visited by a member of the study staff on the second and third day after surgery. The study staff member will ask questions about the subject's ability to think and analyze information.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 50 and older
- Presenting to Ochsner Main Campus with a hip fracture
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intravenous Opioids
|
Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
Other Names:
|
Experimental: Femoral Nerve Catheterization
|
A femoral nerve catheter will be placed prior to surgery in this group.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of participants developing delirium post-operatively
Time Frame: 3 days post-operatively
|
3 days post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of days admitted to the hospital post-operatively
Time Frame: participants will be followed for the duration of the hospital stay, an expected average of 4 days
|
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?
Time Frame: post-op day 2 and again on post-op day 3
|
Two VAS scores, at least 6 hours apart, will be taken from the medical chart on post-op day 2 and again on post-op day 3.
The amount of pain medication (opioids), such as morphine, hydrocodone, oxycodone, etc. consumed will be recorded until discharge.
|
post-op day 2 and again on post-op day 3
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010.198.C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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