A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hip Fracture |
Procedure: Femoral Nerve Catheterization Procedure: Intravenous Opioids |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair? |
- number of participants developing delirium post-operatively [ Time Frame: 3 days post-operatively ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 270 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Leslie Thomas, MD | 504-842-3755 | lesthomas@ochsner.org |
| United States, Louisiana | |
| Ochsner Clinic Foundation | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Thomas lesthomas@ochsner.org | |
| Principal Investigator: Leslie Thomas, MD | |
| Principal Investigator: | Leslie Thomas, MD | Ochsner Health System |
More Information
No publications provided
| Responsible Party: | Leslie Thomas, Anesthesiologist, Ochsner Health System |
| ClinicalTrials.gov Identifier: | NCT01547468 History of Changes |
| Other Study ID Numbers: | 2010.198.C |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ochsner Health System:
|
hip fracture elderly delirium broken hip hip surgery orthopedic orthopedic surgery |
pain anesthesia Ochsner Clinic Ochsner Hospital Leslie Thomas MD New Orleans Louisiana |
Additional relevant MeSH terms:
|
Fractures, Bone Hip Fractures Wounds and Injuries Femoral Fractures Hip Injuries Leg Injuries Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 21, 2013