Improving Pain and Function in Hip Fracture - Full Text View

Sponsors and Collaborators:	Mount Sinai School of Medicine National Institute on Aging (NIA)
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00749489

Purpose

The purpose of this study is to compare two different methods of treating pain after a hip fracture.

Condition	Intervention	Phase
Pain Hip Fractures	Procedure: Femoral Nerve Block	Phase III

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study
Official Title:	Improving Pain and Function in Hip Fracture

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

Pain; 11-point Numeric Rating Scale [ Time Frame: three times daily for pain for the duration of hospital stay (average stay is 4 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Delirium; Confusion Assessment Method (CAM). [ Time Frame: three times daily for pain for the duration of hospital stay (average stay is 4 days) ] [ Designated as safety issue: No ]

Estimated Enrollment:	460
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intervention patients will have a continuous fascia iliaca blocks placed by a regional anesthesiologist 24 hours after the initial single injection femoral nerve block or at the time of surgery.	Procedure: Femoral Nerve Block Patients assigned to the intervention group will have a femoral nerve block administered by the attending emergency department physician. Twenty-four hours after the femoral nerve block or at the time of surgery, an anesthesiologist will insert a continuous fascia iliaca block. Both procedures (femoral nerve block and fascia iliaca blocks) are standard anesthetic techniques that are used in orthopedic procedures but their efficacy as compared to standard opioid therapy has not been evaluated in controlled clinical trials in hip fracture. The medications that will be used in each procedure are as follows: 1) femoral nerve block: 0.5% bupivacaine with 1:300,000 epinephrine; 2) fascia iliaca block: 0.2% ropivacaine will be infused at 5ml/hr.
2: No Intervention

Arms

Assigned Interventions

1: Experimental

Intervention patients will have a continuous fascia iliaca blocks placed by a regional anesthesiologist 24 hours after the initial single injection femoral nerve block or at the time of surgery.

Procedure: Femoral Nerve Block

Patients assigned to the intervention group will have a femoral nerve block administered by the attending emergency department physician. Twenty-four hours after the femoral nerve block or at the time of surgery, an anesthesiologist will insert a continuous fascia iliaca block. Both procedures (femoral nerve block and fascia iliaca blocks) are standard anesthetic techniques that are used in orthopedic procedures but their efficacy as compared to standard opioid therapy has not been evaluated in controlled clinical trials in hip fracture. The medications that will be used in each procedure are as follows: 1) femoral nerve block: 0.5% bupivacaine with 1:300,000 epinephrine; 2) fascia iliaca block: 0.2% ropivacaine will be infused at 5ml/hr.

2: No Intervention

Detailed Description:

This project examines the efficacy and effects of 2 regional anesthesia techniques, femoral nerve blocks (FNB) and fascia iliaca blocks (FIB), on the treatment of peri-operative acute hip (femoral neck, intertrochanteric) fracture pain. Patients age 60 years and over presenting to two New York City emergency departments with hip fracture will be randomized to receive the intervention or usual care. The intervention includes single injection FNB in the ED followed by insertion of a continuous FIB catheter within 24 hours of the single injection FNB plus "as needed" non-opioid/opioid analgesia. Usual care patients will receive conventional therapy with regularly scheduled intravenous or oral opioids plus "as needed" non/opioids/opioids. We will examine the impact of the intervention on patients' self reported pain intensity; systemic opioid requirements; post-operative function; incidence of delirium, treatment related side effects; and hospital length of stay and participation in physical therapy.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All adult patients 60 years of age and over that present to the MSMC ED from 8:00 to 20:00 with a radiographically confirmed hip fracture (femoral neck, intertrochanteric, or peri-capsular) will be screened for study eligibility.

Exclusion Criteria:

History of advanced dementia
Presence of multiple trauma, pathological fractures, bilateral hip fractures, or previous fracture or surgery at the currently fractured site
Patients transferred from another hospital
Patients with cirrhosis or liver failure.
The investigators exclude patients with advanced dementia because the investigators will require patients to self-report their pain intensity.
The investigators exclude these categories of hip fracture because they represent patients with atypical or often problematic clinical circumstances.
The investigators exclude patients under age 60 because our focus is on treatment of pain in older adults. Younger adults (less than age 60) typically present with fractures of different cause (severe and multiple trauma), are less sensitive to the side effects and complications of opioid therapy, are less likely to have delayed or prolonged functional recovery, and are less sensitive to the adverse and sometimes permanent effects of prolonged bed rest (i.e., from pain) on function.
The investigators exclude patients with hepatic dysfunction because the intervention protocol includes administration of acetaminophen which can provoke liver failure in patients with advanced liver disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749489

Contacts

Contact: Taja Ferguson, MPH

212.241.8705

taja.ferguson@mssm.edu

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Beth Israel
New York, New York, United States, 10003

Sponsors and Collaborators

Mount Sinai School of Medicine

National Institute on Aging (NIA)

Investigators

Principal Investigator:	R. Sean Morrison, MD	Mount Sinai School of Medicine
Principal Investigator:	Knox Todd, MD, MPH	Beth Israel

More Information

Additional Information:

National Palliative Care Research Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mount Sinai School of Medicine ( R. Sean Morrison )
Study ID Numbers:	GCO# 06-0721, AG030141-01A1
Study First Received:	September 8, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00749489 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Pain
Hip Fractures
Femoral Fractures
Analgesics

Opioid
Nerve Block
Geriatric
Nerve Stimulation

Study placed in the following topic categories:

Hip Fractures
Femoral Fractures
Ropivacaine
Fractures, Bone
Wounds and Injuries
Anesthetics

Disorders of Environmental Origin
Bupivacaine
Leg Injuries
Pain
Analgesics
Epinephrine

Additional relevant MeSH terms:

Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 07, 2009