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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2022-04-19

Brief Summary

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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

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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.

Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravenous Opioids

Group Type ACTIVE_COMPARATOR

Intravenous Opioids

Intervention Type PROCEDURE

Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.

Femoral Nerve Catheterization

Group Type EXPERIMENTAL

Femoral Nerve Catheterization

Intervention Type PROCEDURE

A femoral nerve catheter will be placed prior to surgery in this group.

Interventions

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Femoral Nerve Catheterization

A femoral nerve catheter will be placed prior to surgery in this group.

Intervention Type PROCEDURE

Intravenous Opioids

Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.

Intervention Type PROCEDURE

Other Intervention Names

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FNC IV opioids

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes