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

This study is currently recruiting participants.
Verified March 2013 by Ochsner Health System
Sponsor:
Collaborator:
American Society of Anesthesiologists
Information provided by (Responsible Party):
Leslie Thomas, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT01547468
First received: February 27, 2012
Last updated: March 14, 2013
Last verified: March 2013

February 27, 2012
March 14, 2013
March 2012
March 2015   (final data collection date for primary outcome measure)
number of participants developing delirium post-operatively [ Time Frame: 3 days post-operatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01547468 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 opioid consumption 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 opioids consumed will be recorded until discharge.
Not Provided
Not Provided
 
A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients
Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hip Fracture
  • Procedure: Femoral Nerve Catheterization
    A femoral nerve catheter will be placed prior to surgery in this group.
    Other Name: FNC
  • Procedure: Intravenous Opioids
    Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
    Other Name: IV opioids
  • Active Comparator: Intravenous Opioids
    Intervention: Procedure: Intravenous Opioids
  • Experimental: Femoral Nerve Catheterization
    Intervention: Procedure: Femoral Nerve Catheterization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact: Leslie Thomas, MD 504-842-3755 lesthomas@ochsner.org
United States
 
NCT01547468
2010.198.C
No
Leslie Thomas, Ochsner Health System
Leslie Thomas
American Society of Anesthesiologists
Principal Investigator: Leslie Thomas, MD Ochsner Health System
Ochsner Health System
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP