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Improving Pain and Function in Hip Fracture

Phase 3
60 Years
Open (Enrolling)
Pain, Hip Fractures

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Trial Information

Improving Pain and Function in 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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pain; 11-point Numeric Rating Scale

Outcome Time Frame:

three times daily for pain for the duration of hospital stay (average stay is 4 days)

Safety Issue:


Principal Investigator

R. Sean Morrison, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:

GCO 06-0721



Start Date:

November 2008

Completion Date:

December 2013

Related Keywords:

  • Pain
  • Hip Fractures
  • Pain
  • Hip Fractures
  • Femoral Fractures
  • Analgesics
  • Opioid
  • Nerve Block
  • Geriatric
  • Nerve Stimulation
  • Fractures, Bone
  • Hip Fractures



MD Anderson Cancer CenterHouston, Texas  77030-4096
Mount Sinai School of MedicineNew York, New York  10029
Maimonides Medical CenterBrooklyn, New York  11219
Beth IsraelNew York, New York  10003