A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients
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| First Received Date ICMJE | February 27, 2012 | ||||
| Last Updated Date | March 14, 2013 | ||||
| Start Date ICMJE | March 2012 | ||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
number of participants developing delirium post-operatively [ Time Frame: 3 days post-operatively ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01547468 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients | ||||
| Official Title ICMJE | Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair? | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Hip Fracture | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 270 | ||||
| Estimated Completion Date | March 2015 | ||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01547468 | ||||
| Other Study ID Numbers ICMJE | 2010.198.C | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Leslie Thomas, Ochsner Health System | ||||
| Study Sponsor ICMJE | Leslie Thomas | ||||
| Collaborators ICMJE | American Society of Anesthesiologists | ||||
| Investigators ICMJE |
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| Information Provided By | Ochsner Health System | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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