Trial record 1 of 96 for:
Open Studies | "Hip Fractures"
Improving Pain and Function in Hip Fracture
This study is currently recruiting participants.
Verified October 2012 by Mount Sinai School of Medicine
Sponsor:
Mount Sinai School of Medicine
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00749489
First received: September 8, 2008
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to compare two different methods of treating pain after a hip fracture.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Hip Fractures |
Procedure: Femoral Nerve Block |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mount Sinai School of Medicine:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749489
Contacts
| Contact: Taja Ferguson, MPH | 212.241.8705 | taja.ferguson@mssm.edu |
Locations
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Principal Investigator: R. Sean Morrison, MD | |
| Beth Israel | Terminated |
| New York, New York, United States, 10003 | |
| Maimonides Medical Center | Recruiting |
| New York, New York, United States, 11219 | |
| Contact: Eitan Dickman, MD EDickman@maimonidesmed.org | |
| United States, Texas | |
| MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Knox Todd, MD, MPH KHTodd@mdanderson.org | |
| Principal Investigator: Knox Todd, MD, MPH | |
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
| Principal Investigator: | R. Sean Morrison, MD | Mount Sinai School of Medicine |
| Principal Investigator: | Knox Todd, MD, MPH | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00749489 History of Changes |
| Other Study ID Numbers: | GCO 06-0721, AG030141-01A1 |
| Study First Received: | September 8, 2008 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Pain Hip Fractures Femoral Fractures Analgesics |
Opioid Nerve Block Geriatric Nerve Stimulation |
Additional relevant MeSH terms:
|
Fractures, Bone Hip Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 16, 2013