A Comparison of Two Pain Control Techniques on Deliruim i... | NCT01547468

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

NCT01547468

Sponsor

Leslie Thomas

Status

Withdrawn

Last Update Posted

Apr 27, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hip Fracture

Interventions

Femoral Nerve Catheterization
Intravenous Opioids

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inactivity and unable to complete due to manpower issues

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Apr 19, 2022Actual

Completion Date

Apr 19, 2022Actual

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Mar 2, 2012

First Posted Date

Mar 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 27, 2022Actual

Name	Class
American Society of Anesthesiologists	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous Opioids	Active Comparator		Procedure: Intravenous Opioids
Femoral Nerve Catheterization	Experimental		Procedure: Femoral Nerve Catheterization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Femoral Nerve Catheterization	Procedure	A femoral nerve catheter will be placed prior to surgery in this group.	Femoral Nerve Catheterization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participants developing delirium post-operatively		3 days post-operatively

Secondary Outcomes

Measure	Description	Time Frame
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
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?

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leslie Thomas, MD	Ochsner Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner Clinic Foundation		New Orleans	Louisiana	70121	United States

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures
D003693	Delirium
D010146	Pain

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000701	Analgesics, Opioid

Ancestor Terms

ID	Term
D009294	Narcotics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided