Clinical trial NCT01547468: A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients
Official title: Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hip Fracture
Keywords: hip fracture
elderly
delirium
broken hip
hip
surgery
orthopedic
orthopedic surgery
pain
anesthesia
Ochsner Clinic
Ochsner Hospital
Leslie Thomas MD
New Orleans
Louisiana
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: American Society of Anesthesiologists
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 criteria: 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

Primary outcomes:
measure: number of participants developing delirium post-operatively
timeFrame: 3 days post-operatively
Secondary outcomes:
measure: the number of days admitted to the hospital post-operatively
timeFrame: participants will be followed for the duration of the hospital stay, an expected average of 4 days
measure: 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?
timeFrame: post-op day 2 and again on post-op day 3
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Leslie Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: