Improving Pain and Function in Hip Fracture

This study is currently recruiting participants.
Verified October 2012 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00749489
First received: September 8, 2008
Last updated: October 10, 2012
Last verified: October 2012

September 8, 2008
October 10, 2012
November 2008
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00749489 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Improving Pain and Function in Hip Fracture
Improving Pain and Function in Hip Fracture

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Hip Fractures
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.
  • 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.
    Intervention: Procedure: Femoral Nerve Block
  • No Intervention: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact: Taja Ferguson, MPH 212.241.8705 taja.ferguson@mssm.edu
United States
 
NCT00749489
GCO 06-0721, AG030141-01A1
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
National Institute on Aging (NIA)
Principal Investigator: R. Sean Morrison, MD Mount Sinai School of Medicine
Principal Investigator: Knox Todd, MD, MPH M.D. Anderson Cancer Center
Mount Sinai School of Medicine
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP