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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Improving Pain and Function in Hip Fracture|
- 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 ]
- 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 ]
|Study Start Date:||November 2008|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749489
|United States, New York|
|New York, New York, United States, 10003|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Maimonides Medical Center|
|New York, New York, United States, 11219|
|Principal Investigator:||R. Sean Morrison, MD||Mount Sinai School of Medicine|
|Principal Investigator:||Knox Todd, MD, MPH||M.D. Anderson Cancer Center|