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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Hip Fracture
Procedure: Femoral Nerve Catheterization
Procedure: Intravenous Opioids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • number of participants developing delirium post-operatively [ Time Frame: 3 days post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 270
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravenous Opioids Procedure: Intravenous Opioids
Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
Other Name: IV opioids
Experimental: Femoral Nerve Catheterization Procedure: Femoral Nerve Catheterization
A femoral nerve catheter will be placed prior to surgery in this group.
Other Name: FNC

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547468

Contacts
Contact: Leslie Thomas, MD 504-842-3755 lesthomas@ochsner.org

Locations
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Thomas       lesthomas@ochsner.org   
Principal Investigator: Leslie Thomas, MD         
Sponsors and Collaborators
Leslie Thomas
American Society of Anesthesiologists
Investigators
Principal Investigator: Leslie Thomas, MD Ochsner Health System
  More Information

No publications provided

Responsible Party: Leslie Thomas, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01547468     History of Changes
Other Study ID Numbers: 2010.198.C
Study First Received: February 27, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
hip fracture
broken hip
elderly
delirium
hip
surgery
orthopedic
orthopedic surgery
pain
anesthesia
Ochsner Clinic
Ochsner Hospital
Leslie Thomas MD
New Orleans
Louisiana

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014