Improving Pain and Function in Hip Fracture

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00749489

Collaborator

National Institute on Aging (NIA) (NIH)

164

Enrollment

Locations

Arms

65.9

Duration (Months)

54.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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

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 :

Nov 1, 2008

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

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

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

Pain; 11-point Numeric Rating Scale [three times daily for pain for the duration of hospital stay (average stay is 4 days)]

Secondary Outcome Measures

Delirium; Confusion Assessment Method (CAM). [three times daily for pain for the duration of hospital stay (average stay is 4 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel	New York	New York	United States	10003
2	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
3	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)

Investigators

Principal Investigator: R. Sean Morrison, MD, Icahn School of Medicine at Mount Sinai
Principal Investigator: Knox Todd, MD, MPH, M.D. Anderson Cancer Center