Improving Pain and Function in Hip Fracture

Pain Clinical Trial

Official title:

Improving Pain and Function in Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749489
• Other study ID #: GCO 06-0721
• Secondary ID: AG030141-01 A1
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2008
• Last updated: June 24, 2014
• Start date: November 2008
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Maimonides Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain; 11-point Numeric Rating Scale		three times daily for pain for the duration of hospital stay (average stay is 4 days)	No
Secondary	Delirium; Confusion Assessment Method (CAM).		three times daily for pain for the duration of hospital stay (average stay is 4 days)	No

External Links

•   National Palliative Care Research Center