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Improving Pain and Function in Hip Fracture

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ClinicalTrials.gov Identifier: NCT00749489
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : June 25, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare two different methods of treating pain after a hip fracture.

Condition or disease Intervention/treatment Phase
Pain Hip Fractures Procedure: Femoral Nerve Block Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Pain and Function in Hip Fracture
Study Start Date : November 2008
Primary Completion Date : May 2014
Study Completion Date : May 2014

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Femoral Nerve Block
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.
No Intervention: No Intervention
No intervention

Outcome Measures

Primary Outcome Measures :
  1. Pain; 11-point Numeric Rating Scale [ Time Frame: three times daily for pain for the duration of hospital stay (average stay is 4 days) ]

Secondary Outcome Measures :
  1. Delirium; Confusion Assessment Method (CAM). [ Time Frame: three times daily for pain for the duration of hospital stay (average stay is 4 days) ]

Eligibility Criteria

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749489

United States, New York
Beth Israel
New York, New York, United States, 10003
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Maimonides Medical Center
New York, New York, United States, 11219
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Principal Investigator: R. Sean Morrison, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Knox Todd, MD, MPH M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00749489     History of Changes
Other Study ID Numbers: GCO 06-0721
AG030141-01 A1 ( Other Grant/Funding Number: National Institute on Aging (NIA) )
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Icahn School of Medicine at Mount Sinai:
Hip Fractures
Femoral Fractures
Nerve Block
Nerve Stimulation

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries