A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients

Leslie Thomas

Status: Withdrawn

Conditions: Hip Fracture

Treatments: Procedure: Intravenous Opioids; Procedure: Femoral Nerve Catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT01547468

2010.198.C

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intravenous Opioids

Active Comparator group

Treatment:

Procedure: Intravenous Opioids

Femoral Nerve Catheterization

Experimental group

Treatment:

Procedure: Femoral Nerve Catheterization