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

Primary Purpose

Hip Fracture

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Femoral Nerve Catheterization
Intravenous Opioids
Sponsored by
Leslie Thomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fracture focused on measuring hip fracture, elderly, delirium, broken hip, hip, surgery, orthopedic, orthopedic surgery, pain, anesthesia, Ochsner Clinic, Ochsner Hospital, Leslie Thomas MD, New Orleans, Louisiana

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Ochsner Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous Opioids

Femoral Nerve Catheterization

Arm Description

Outcomes

Primary Outcome Measures

number of participants developing delirium post-operatively

Secondary Outcome Measures

the number of days admitted to the hospital post-operatively
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?
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.

Full Information

First Posted
February 27, 2012
Last Updated
April 19, 2022
Sponsor
Leslie Thomas
Collaborators
American Society of Anesthesiologists
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1. Study Identification

Unique Protocol Identification Number
NCT01547468
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
inactivity and unable to complete due to manpower issues
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leslie Thomas
Collaborators
American Society of Anesthesiologists

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Opioids
Arm Type
Active Comparator
Arm Title
Femoral Nerve Catheterization
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Catheterization
Other Intervention Name(s)
FNC
Intervention Description
A femoral nerve catheter will be placed prior to surgery in this group.
Intervention Type
Procedure
Intervention Name(s)
Intravenous Opioids
Other Intervention Name(s)
IV opioids
Intervention Description
Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
Primary Outcome Measure Information:
Title
number of participants developing delirium post-operatively
Time Frame
3 days post-operatively
Secondary Outcome Measure Information:
Title
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
Title
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?
Description
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.
Time Frame
post-op day 2 and again on post-op day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Thomas, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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