Improving Pain and Function in Hip Fracture

Mount Sinai Health System

Status and phase: Completed; Phase 3

Conditions: Hip Fractures; Pain

Treatments: Procedure: Femoral Nerve Block

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00749489

AG030141-01 A1 (Other Grant/Funding Number)

GCO 06-0721

Details and patient eligibility

About

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

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Femoral Nerve Block

Experimental group

Description:

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.

Treatment:

Procedure: Femoral Nerve Block

No Intervention

No Intervention group

Description:

No intervention