A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients
|ClinicalTrials.gov Identifier: NCT01547468|
Recruitment Status : Unknown
Verified March 2013 by Leslie Thomas, Ochsner Health System.
Recruitment status was: Recruiting
First Posted : March 7, 2012
Last Update Posted : March 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture||Procedure: Femoral Nerve Catheterization Procedure: Intravenous Opioids||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
|Active Comparator: Intravenous Opioids||
Procedure: Intravenous Opioids
Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
Other Name: IV opioids
|Experimental: Femoral Nerve Catheterization||
Procedure: Femoral Nerve Catheterization
A femoral nerve catheter will be placed prior to surgery in this group.
Other Name: FNC
- number of participants developing delirium post-operatively [ Time Frame: 3 days post-operatively ]
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547468
|Contact: Leslie Thomas, MDfirstname.lastname@example.org|
|United States, Louisiana|
|Ochsner Clinic Foundation||Recruiting|
|New Orleans, Louisiana, United States, 70121|
|Contact: Thomas email@example.com|
|Principal Investigator: Leslie Thomas, MD|
|Principal Investigator:||Leslie Thomas, MD||Ochsner Health System|