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

Hip Fracture Clinical Trial

Official title:

Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01547468
• Other study ID #: 2010.198.C
• Status: Withdrawn
• Phase: N/A
• Start date: March 2012
• Est. completion date: April 19, 2022

Study information

• Verified date: April 2022
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• Femoral Nerve Catheterization
A femoral nerve catheter will be placed prior to surgery in this group.
• Intravenous Opioids
Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Leslie Thomas	American Society of Anesthesiologists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants developing delirium post-operatively		3 days post-operatively
Secondary	the number of days admitted to the hospital post-operatively		participants will be followed for the duration of the hospital stay, an expected average of 4 days
Secondary	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.	post-op day 2 and again on post-op day 3